Trial · Interventional
CompletedPhase 1/2Registry dataSafety 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
- Ph 1/2
Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic Malignancies
NCT01413568Apr 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.
Phase I Study - safety and tolerability of POL6326 as a mobilization agent.
Time frame · 30 days
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)
Phase I Study - define maximum tolerated dose of POL6326
Time frame · 30 days
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
Phase II Study - pharmacokinetics and pharmacodynamics of IV POL6326
Time frame · Day 1-3
Registry description
Stem cell and T-cell phenotyping
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)
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
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