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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD

NCTNCT02525029 (opens ClinicalTrials.gov in a new tab)Other id2014LS020Other idNCI-2015-02022
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
53 participants (actual)
Sponsor
Masonic Cancer Center, University of Minnesota · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2016
Primary completion
May 2021
Completion
Apr 2022
First posted
17 Aug 2015 (estimated)
Last update posted
14 Dec 2023
Conditions
Graft vs Host Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022
  1. Ph 1/2

    Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD

    NCT02525029

    Mar 2016 to Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (Arm 1) or refractory/dependent (Arm 2) aGVHD.

Interventions

  • Pregnyl®Drug

Arms20

  • Experimental

    Arm 1: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 1: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2A: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2A: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2A: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2B: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2B: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^2

    Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.

  • Experimental

    Arm 1: Phase 2 MTD

    After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low

  • Experimental

    Arm 2A: MTD

    After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low

  • Experimental

    Arm 2B: MTD

    After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Phase I: MTD (USP hCG)

    Time frame · Day 14 after initiation of protocol therapy

    Registry description

    Maximum tolerated dose (MTD) of Pregnyl® when given with standard immunosuppressive therapy in pediatric and adult patients with high-risk or refractory acute graft-versus-host disease (aGVHD). Dosage measured as (USP hCG/pg EGF/mm\^2).

  2. Phase I: MTD (pg EGF/m^2)

    Time frame · Day 14 after initiation of protocol therapy

    Registry description

    Maximum tolerated dose (MTD) of Pregnyl® when given with standard immunosuppressive therapy in pediatric and adult patients with high-risk or refractory acute graft-versus-host disease (aGVHD). Dosage measured as (USP hCG/pg EGF/m\^2).

  3. Number of Patients With Complete Response

    Time frame · Day 28 after initiation of protocol therapy

    Registry description

    Percentage of complete response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. Complete response is defined as a Stage of 0 for all organs with no additional intervening therapy for their GVHD.

  4. Number of Patients With Partial Response

    Time frame · Day 28 after initiation of protocol therapy

    Registry description

    Percentage of partial response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. Partial response is defined as improvement by at least 1 stage in all involved organs without progression in others with no additional intervening therapy for their GVHD.

  5. Number of Patients With Mixed Response

    Time frame · Day 28 after initiation of protocol therapy

    Registry description

    Percentage of mixed response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. Mixed Response is defined as improvement in one organ with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ.

  6. Number of Patients With No Response

    Time frame · Day 28 after initiation of protocol therapy

    Registry description

    Percentage of no response among surviving patients at day 28 after initiation of protocol therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD. No response is defined as deterioration of any organ involved.

Secondary outcomes(5)

  1. Number of Participants With Adverse Events as a Measure of Safety and Feasibility of hCG Supplementation With Pregnyl®

    Time frame · Day 70 after initiation of protocol therapy

    Registry description

    Safety and feasibility of hCG supplementation with Pregnyl® in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk or refractory aGVHD.

  2. Number of Participants With Incidence of aGVHD Flare

    Time frame · Day 28 after initiation of protocol therapy

    Registry description

    Incidence of acute GVHD flare after CR/PR requiring increase of steroids or other systemic treatment at day 28.

  3. Number of Participants With Incidence of aGVHD Flare

    Time frame · Day 56 after initiation of protocol therapy

    Registry description

    Incidence of acute GVHD flare after CR/PR requiring increase of steroids or other systemic treatment at day 56.

  4. Rate of Participants Who Fail Treatment at Day 28

    Time frame · Day 28 after initiation of protocol therapy

    Registry description

    Rate of treatment failure for acute GVHD at day 28 after initiation of protocol therapy to historical controls.

  5. Rate of Participants Who Fail Treatment at Day 56

    Time frame · Day 56 after initiation of protocol therapy

    Registry description

    Rate of treatment failure for acute GVHD at day 56 after initiation of protocol therapy to historical controls.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 14 after initiation of protocol therapy

Phase I: MTD (USP hCG)

GroupValue (Pregnyl dosage (USP hCG))
1: High-Risk aGVHD2000
2a: Steroid-Dependent aGVHD2000
2b: Steroid-Refractory aGVHD5000
Primary outcomeNumber· Day 14 after initiation of protocol therapy

Phase I: MTD (pg EGF/m^2)

GroupValue (Pregnyl dosage (pg EGF/m^2))
1: High-Risk aGVHD14000
2a: Steroid-Dependent aGVHD14000
2b: Steroid-Refractory aGVHD34000
Primary outcomeNumber· Day 28 after initiation of protocol therapy

Number of Patients With Complete Response

GroupValue (participants)
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^22
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^22
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^24
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^27
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^21
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^23
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^25
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^22
Arm 2B: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^21
Primary outcomeNumber· Day 28 after initiation of protocol therapy

Number of Patients With Partial Response

GroupValue (participants)
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2B: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^21
Primary outcomeNumber· Day 28 after initiation of protocol therapy

Number of Patients With Mixed Response

GroupValue (participants)
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^22
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^22
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2B: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^20
Primary outcomeNumber· Day 28 after initiation of protocol therapy

Number of Patients With No Response

GroupValue (participants)
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^24
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^23
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2B: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^21
Secondary and other outcome results(2)
Secondary outcomeCount of participants· Day 70 after initiation of protocol therapy

Number of Participants With Adverse Events as a Measure of Safety and Feasibility of hCG Supplementation With Pregnyl®

GroupValue (Participants)
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^21
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^21
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^23
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^26
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^21
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^22
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^25
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^22
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^23
Arm 2B: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^22
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^21
Secondary outcomeNumber· Day 28 after initiation of protocol therapy

Number of Participants With Incidence of aGVHD Flare

GroupValue (participants)
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^23
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^25
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2B: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^20
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^21
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^21

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.0 / 21 / 21 / 2
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.1 / 21 / 21 / 2
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.0 / 91 / 93 / 9
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.0 / 132 / 136 / 13
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.0 / 11 / 11 / 1
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.1 / 42 / 42 / 4
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.0 / 84 / 85 / 8
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.0 / 22 / 22 / 2
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.1 / 11 / 11 / 1
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.0 / 55 / 53 / 5
Arm 2B: Phase 2 Dose Level 3 2,000 USPStandard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.1 / 10 / 11 / 1
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m2Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.1 / 22 / 22 / 2
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/mStandard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has toxicity that meets the definition of dose limiting, the patient can drop down one dose level for the next injection and continue treatment. Pregnyl®: Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7 Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Study will use Continual Reassessment Method (CRM) to establish a maximum tolerated dose (MTD). Step -2: 125 USP hCG/875 pg EGF/m2 Step -1: 250 USP hCG/1,750 pg EGF/m2 Step 1 (start): 500 USP hCG/3,500 pg EGF/m2 Step 2: 1,000 USP hCG/7,000 pg EGF/m2 Step 3: 2,000 USP hCG/14,000 pg EGF/m2 Step 4 (Arm 2b only): 3,500 USP hCG/24,500 pg EGF/m2 Step 5 (Arm 2b only): 5,000 USP hCG/35,000 pg EGF/m Phase II: the dose of Pregnyl will be that identified as the MTD during phase I.1 / 33 / 31 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHoltan SG, Hoeschen A, Cao Q, Ustun C, Betts BC, Jurdi NE, Maakaron J, Rashidi A, Miller JS, Wagner JE, Blazar BR, Jacobson PA, Panoskaltsis-Mortari A, Weisdorf DJ, MacMillan ML. Phase II, Open-Label Clinical Trial of Urinary-Derived Human Chorionic Gonadotropin/Epidermal Growth Factor for Life-Threatening Acute Graft-versus-Host Disease. Transplant Cell Ther. 2023 Aug;29(8):509.e1-509.e8. doi: 10.1016/j.jtct.2023.05.021. Epub 2023 Jun 4. PMID 37279855
  • DerivedHoltan SG, Hoeschen AL, Cao Q, Arora M, Bachanova V, Brunstein CG, Miller JS, Rashidi A, Slungaard A, Ustun C, Vercellotti GM, Warlick ED, Betts BC, El Jurdi N, He F, Chen C, Gandhi I, Wagner JE, Blazar BR, Jacobson PA, Shabaneh A, Wang J, Panoskaltsis-Mortari A, MacMillan ML, Weisdorf DJ. Facilitating resolution of life-threatening acute GVHD with human chorionic gonadotropin and epidermal growth factor. Blood Adv. 2020 Apr 14;4(7):1284-1295. doi: 10.1182/bloodadvances.2019001259. PMID 32236525

Eligibility

Who could join, as posted.

Sex
All
Age
up to 76 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Acute graft versus host disease (GVHD) fitting one of the following categories: * High-Risk aGVHD (ARM 1): Pediatric or adult (ages 12-76 years) HCT recipients with high-risk acute GVHD, as determined by the refined MN acute GVHD risk score: http://z.umn.edu/MNAcuteGVHDRiskScore OR high risk on the basis of blood biomarkers (Ann Arbor Score 3 or amphiregulin ≥ 33 pg/ml) or * Steroid-Refractory aGVHD (ARM 2): Pediatric or adult (ages 12-76 years) HCT recipient with grade II-IV steroid refractory or steroid-dependent acute GVHD, defined as any one of the following: * No response of acute GVHD after at least 4 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent * Progression of acute GVHD within 3 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent * Failure to improve to at least grade II acute GVHD after 14 days of systemic corticosteroids, with initial doses of at least 2 mg/kg prednisone or equivalent * Flare of acute GVHD of at least grade II/IV severity despite tapering dose of steroids being \> 0.5 mg/kg/day. * Adequate organ function at study enrollment defined as: * Renal: 1.73m2Serum creatinine ≤2.5x upper limit of normal (ULN) * Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35% * Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds) Exclusion Criteria: * Progressive malignancy * Diagnosis of a hormone responsive malignancy * Uncontrolled infection at initiation of protocol treatment * Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible * Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status * Pregnancy as assessed on baseline blood hCG level * Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations) * Women or men of childbearing potential unwilling to take adequate precautions to avoid pregnancy from the start of protocol treatment through 28 days after the last treatment Screening Inclusion Criteria: * Pediatric or adult (ages 0-76 years) HCT recipients * Suspected high risk GVHD * Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)

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