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Trial · Interventional

CompletedPhase 1/2Registry data

Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
38 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2012
Primary completion
Nov 2015
Completion
Dec 2015
First posted
10 Aug 2011 (estimated)
Last update posted
26 Feb 2016 (estimated)
Conditions
Acute Myeloid Leukemia in Remission · Adult Acute Lymphoblastic Leukemia in Remission · Chronic Myelogenous Leukemia (CML) · Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease (HD) in 2nd or Greater Complete Remission, Partial Remission · Chronic Lymphocytic Leukemia (CLL) · Multiple Myeloma (MM) · Myelodysplastic Syndrome (MDS) · Myeloproliferative Disorders

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 1/2

    Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies

    NCT01413568

    Apr 2012 to Dec 2015

Registry summary

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

Determine the safety and tolerability of POL6326 when used as a single mobilization agent.

Interventions

  • POL6326Drug
  • LeukapheresisProcedure
  • PBSC TransplantProcedure

Arms2

  • Experimental

    Donor (Phase I and Phase II)

    On Day 1 (and possibly Day 2) POL6326 IV Infusion with increasing dose levels in Phase I or with random dose assignment (from the 2 selected from Phase I) in phase II Leukapheresis collection on Day 1 (and possibly Day 2)

  • Experimental

    Recipient

    Day 0 - PBSC transplant with stem cells mobilized with IV POL6326

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Phase I Study - safety and tolerability of POL6326 as a mobilization agent.

    Time frame · 30 days

  2. Phase II Study - determine the number of allogeneic donors who require a second leukapheresis

    Time frame · 2 days

    Registry description

    Determine the number of allogeneic donors which collect \>= 2 mill CD34+ cells with one or two leukapheresis procedures treated with IV POL6326. Comparison with historic group of donors who were mobilized with 240 µg/kg SC plerixafor.

Secondary outcomes(5)
  1. Phase I Study - define maximum tolerated dose of POL6326

    Time frame · 30 days

  2. Phase II Study - the proportion of HLA-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion who are safely mobilized

    Time frame · 30 days

    Registry description

    To estimate the proportion of HLA-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom \> 2 mill CD34+ cells/kg recipient weight are safely mobilized following one or two leukapheresis procedures

  3. Phase II Study - pharmacokinetics and pharmacodynamics of IV POL6326

    Time frame · Day 1-3

    Registry description

    Stem cell and T-cell phenotyping

  4. Phase II Study - rate of acute GVHD and chronic GVHD in patients who receive IV POL6326 mobilized peripheral blood stem cells.

    Time frame · Day 100 (+/- 7 days) or Day 365 (+/-14 days)

    Registry description

    Acute GVHD - Day 100 (+/- 7 days) Chronic GVHD - Day 365 (+/- 14 days)

  5. Phase II Study - kinetics of neutrophil and platelet engraftment in recipients of POL6326 mobilized peripheral blood stem cells.

    Time frame · Day 365 (+/- 14 days)

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Donor Inclusion Criteria * Donor must be 18 to 70 years of age inclusive. * Donor must be a 6/6 HLA-matched sibling willing to donate PBSC for transplant. * Donor must have adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia. * Donor must have adequate renal function as defined by a minimum creatinine clearance (CrCl) value of \>30 ml/min. * Donor must have adequate hepatic function as defined by a total bilirubin \<3x upper limit of normal. * Donor must have adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality and no history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication. * Donor must be HIV-1\&2 antibody and HTLV-1\&2 antibody sero-negative by FDA licensed test. * Donor must have an ECOG performance status of 0 or 1. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Donor must demonstrate ability to be compliant with study regimen. * Donor must be able to understand and willing to sign an IRB approved written informed consent document. Recipient Inclusion Criteria * Recipient must have available the successful collection of a POL62326 mobilized product. * Recipient must be 18 to 75 years of age inclusive. * Recipient must have a 6/6 HLA-matched sibling willing to donate PBSC for transplant. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Recipient must have one of the following diagnoses: * Acute myelogenous leukemia (AML) in 1st or subsequent remission * Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission * Chronic myelogenous leukemia (CML) * Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission * Chronic lymphocytic leukemia (CLL) * Multiple myeloma (MM) * Myelodysplastic syndrome (MDS) * Myeloproliferative disorder (MPD) * Recipient must have adequate cardiac function with a left ventricular ejection fraction \> 40%. * Recipient must have adequate pulmonary function defined as NO severe or symptomatic restrictive or obstructive lung disease, and formal pulmonary function testing showing an FEV1 \>50% (predicted) and a DLCO \>40% (predicted), corrected for hemoglobin. * Recipient must have adequate hepatic function as defined by a total bilirubin \<3x upper limit of normal or absence of hepatic fibrosis/cirrhosis. * Recipient must have adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous CNS tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain. * Recipient must be HIV-1\&2 antibody and HTLV-1\&2 antibody sero-negative by FDA licensed test. * Recipient must have an ECOG performance status of 0 or 1. * Recipient must demonstrate ability to be compliant with medical regimen. * Recipient must have life expectancy of greater than 2 months. * Recipient must be able to understand and willing to sign an IRB approved written informed consent document. Donor Exclusion Criteria * Donor must not have an active infection at the time of study entry. * Donor must not have active alcohol or substance abuse within 6 months of study entry. * Donor must not be currently enrolled on another investigational agent study. * Donor must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation. * Donor must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * If female and of child-bearing age, donor must not be pregnant or breastfeeding. Recipient Exclusion Criteria * Recipient must not have had (the following therapies within the following timeframe): * Investigative drugs within 21 days * Recipient must have no evidence of active infection at the time of the transplant preparative regimen or at time of transplantation. * Recipient must have no active alcohol or substance abuse within 6 months of study entry. * Recipient must not be pregnant and/or breastfeeding.

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