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

NCT01413568 | Completed Phase 1 DMC

• 2 other identifiers: 201112026POL-4
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

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

  30 days

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

  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.

  2 days

Secondary Outcomes (5)

• Phase I Study - define maximum tolerated dose of POL6326

  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

  30 days

• Phase II Study - pharmacokinetics and pharmacodynamics of IV POL6326

  Day 1-3

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

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

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

  Day 365 (+/- 14 days)

Study Arms (2)

Donor (Phase I and Phase II)

EXPERIMENTAL

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)

Drug: POL6326; Procedure: Leukapheresis

Recipient

EXPERIMENTAL

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

Procedure: PBSC Transplant

Interventions

POL6326 DRUG

Donor (Phase I and Phase II)

Leukapheresis PROCEDURE

Donor (Phase I and Phase II)

PBSC Transplant PROCEDURE

Recipient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Polyphor Ltd.: lead

Study Sites (2)

University of Kansas Cancer Center

Kansas City, Kansas, 66205, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Non-Hodgkin; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma; Myelodysplastic Syndromes; Myeloproliferative Disorders

Interventions

balixafortide; Leukapheresis

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Daniel Couriel, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 10, 2011
• Study Start: April 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

US (2)