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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Preservation of Ovarian Function After Hematopoietic Cell Transplant

NCTNCT01343368 (opens ClinicalTrials.gov in a new tab)Other id2010LS053Other id012M93555
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Jul 2011
Primary completion
Apr 2015
Completion
Apr 2015
First posted
28 Apr 2011 (estimated)
Last update posted
5 Dec 2017
Conditions
Multiple Myeloma · Non-Hodgkin Lymphoma · Hodgkin Disease · Acute Myeloid Leukemia · Myeloproliferative Disorders

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. Ph 2

    Preservation of Ovarian Function After Hematopoietic Cell Transplant

    NCT01343368

    Jul 2011 to Apr 2015

    Terminated

Registry summary

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

Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

Interventions

  • LeuprolideDrug
  • hematopoietic cell transplantBiological
  • reduced intensity allogeneic HCTBiological

Arms2

  • Experimental

    Interventional - Received Leuprolide

    Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.

  • Active comparator

    Observational Arm

    Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Comparison of Number of Patients With Ovarian Failure

    Time frame · Through Day 180 Post Transplant

    Registry description

    Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH \>40 IU/L) after transplant.

Secondary outcomes(14)

  1. Comparison of Number of Patients Who Stopped Menstrual Bleeding

    Time frame · From Baseline Through Day 365

    Registry description

    Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant

  2. Comparison of Follicle Stimulating Hormone (FSH) Levels

    Time frame · Baseline

    Registry description

    Comparison of treatment arms; interventional versus observational average FSH levels.

  3. Comparison of Follicle Stimulating Hormone (FSH) Levels

    Time frame · Day 100

    Registry description

    Comparison of treatment arms; interventional versus observational average FSH levels.

  4. Comparison of Follicle Stimulating Hormone (FSH) Levels

    Time frame · Day 180

    Registry description

    Comparison of treatment arms; interventional versus observational average FSH levels.

  5. Comparison of Follicle Stimulating Hormone (FSH) Levels

    Time frame · 1 year

    Registry description

    Comparison of treatment arms; interventional versus observational average FSH levels.

  6. Comparison of Follicle Stimulating Hormone (FSH) Levels

    Time frame · 2 years

    Registry description

    Comparison of treatment arms; interventional versus observational average FSH levels.

  7. Comparison of Number of Patients Who Resumed Menstrual Cycles

    Time frame · Day 365 Post Transplant

    Registry description

    Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant

  8. Comparison of Lutineizing Hormone (LH) Levels

    Time frame · Baseline

    Registry description

    Comparison of treatment arms; interventional versus observational average LH levels during study.

  9. Comparison of Luteinizing Hormone (LH) Levels

    Time frame · Day 100

    Registry description

    Comparison of treatment arms; interventional versus observational average LH levels during study.

  10. Comparison of Luteinizing Hormone (LH) Levels

    Time frame · Day 180

    Registry description

    Comparison of treatment arms; interventional versus observational average LH levels during study.

  11. Comparison of Luteinizing Hormone (LH) Levels

    Time frame · 1 year

    Registry description

    Comparison of treatment arms; interventional versus observational average LH levels during study.

  12. Comparison of Leuprolide Hormone (LH) Levels

    Time frame · 2 years

    Registry description

    Comparison of treatment arms; interventional versus observational average LH levels during study.

  13. Comparison of Antimullerian Hormone (AMH) Levels After Transplant

    Time frame · Day Prior to Transplant

    Registry description

    Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

  14. Comparison of Antimullerian Hormone (AMH) Levels After Transplant

    Time frame · Day 180 after Transplant

    Registry description

    Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

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 outcomeCount of participants· Through Day 180 Post Transplant

Comparison of Number of Patients With Ovarian Failure

GroupValue (Participants)
Interventional - Received Leuprolide3
Observational Arm1
Secondary and other outcome results(7)
Secondary outcomeCount of participants· From Baseline Through Day 365

Comparison of Number of Patients Who Stopped Menstrual Bleeding

GroupValue (Participants)
Interventional - Received Leuprolide2
Observational Arm0
Secondary outcomeMean· Baseline

Comparison of Follicle Stimulating Hormone (FSH) Levels

GroupValue (IU/L)Spread
Interventional - Received Leuprolide9.38.0
Observational Arm4.41.7
Secondary outcomeMean· Day 100

Comparison of Follicle Stimulating Hormone (FSH) Levels

GroupValue (IU/L)Spread
Interventional - Received Leuprolide18.419.5
Observational Arm9.112.7
Secondary outcomeMean· Day 180

Comparison of Follicle Stimulating Hormone (FSH) Levels

GroupValue (IU/L)Spread
Interventional - Received Leuprolide47.040.1
Observational Arm4.74.7
Secondary outcomeMean· 1 year

Comparison of Follicle Stimulating Hormone (FSH) Levels

GroupValue (IU/L)Spread
Interventional - Received Leuprolide61.597.6
Observational Arm48.884.5
Secondary outcomeMean· 2 years

Comparison of Follicle Stimulating Hormone (FSH) Levels

GroupValue (IU/L)Spread
Interventional - Received Leuprolidenot posted–
Observational Arm7.14.6
Secondary outcomeCount of participants· Day 365 Post Transplant

Comparison of Number of Patients Who Resumed Menstrual Cycles

GroupValue (Participants)
Interventional - Received Leuprolide2
Observational Arm4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Interventional - Received LeuprolideLong-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.–0 / 73 / 7
Observational ArmWomen undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.–0 / 100 / 10

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.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Interventional Arm: * Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT) * Post-menarchal female \< or = 50 years of age * Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty * Those women who have an FSH \> 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis. * Observational Arm: * Eligible for reduced intensity allogeneic HCT * Post-menarchal female ≤ 50 years of age * Normal AMH level and/or FSH/LH for age/stage of puberty * Those women who an FSH \>40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis. Exclusion Criteria: * All Arms: * History of ovarian cancer * Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact. * Use of GnRH agonist in last 12 months will exclude patients if lab results are not available to demonstrate adequate ovarian function prior to initiation of GnRH therapy.

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