Overview

This trial is active, not recruiting.

Conditions for donors:, related donors donating pbsc to a family member, for recipients:, acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, non-hodgkin's lymphoma, hodgkin's disease, chronic lymphocytic leukemia
Treatment plerixafor
Phase phase 2
Sponsor Center for International Blood and Marrow Transplant Research
Collaborator Genzyme, a Sanofi Company
Start date May 2013
End date July 2016
Trial size 64 participants
Trial identifier NCT01696461, 09-PLEX

Summary

This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
plerixafor Mozobil

Primary Outcomes

Measure
The proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis
time frame: donation

Secondary Outcomes

Measure
incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor
time frame: baseline, donation
Characterize the adverse effects experienced by donors receiving plerixafor up to one year post donation
time frame: baseline, donation, 1 week, 1 month, 6 months, 1 year
The incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with plerixafor
time frame: Day 21, 28, 56, 100, 180, 270, 365
Description of T-cell (CD3+) and myeloid (CD33+) chimerism after transplantation of hematopoietic cells mobilized with plerixafor
time frame: Day 28, 100, 180, 365
Incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with plerixafor
time frame: Day 21, 28, 56, 100, 180, 270, 365
Incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with plerixafor
time frame: Day 21, 28, 56, 100, 180, 270, 365
Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor
time frame: Day 28, 100, 180, 365
incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with plerixafor in CMV seropositive recipients
time frame: Day 100, 180, 365
incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with plerixafor
time frame: Day 21, 28, 56, 100, 180, 270, 365
probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor
time frame: Day 21, 28, 56, 100, 180, 270, 365
describe the cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/NK-cells)
time frame: donation

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: Donor: - Donor eligibility will be determined according to applicable federal, state and local regulations and institutional standards - 18-65 years of age - 6/6 HLA-matched sibling - Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor - Serum creatinine <2.0mg/dl Recipient: - 18 to 65 years of age - 6/6 HLA antigen matched sibling willing to donate PBSC for transplant - Fulfill individual Transplant Center Criteria for transplant - One of the following diagnoses: - Acute myelogenous leukemia (AML) in 1st remission or beyond with <5% marrow blasts and no circulating blasts. Marrow must be done within 30 days of the start of transplant conditioning regimen in alignment with other pre-transplant assessments. - Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with <5% marrow blasts and no circulating blasts - Myelodysplastic syndrome, either intermediate-1,2, or high risk by International Prognostic Scoring System or transfusion dependent - Chronic myelogenous leukemia (CML) failing or intolerant to tyrosine kinase inhibitor based therapy - Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission, or in relapse (but with at least stable disease after most recent therapy) - Chronic lymphocytic leukemia (CLL), relapsing after at least one prior regimen, or in remission with 17p deletion - Serum creatinine must be <2.0mg/dl - Total bilirubin and AST <3x normal - Infectious disease marker (IDM) monitoring will be performed per institutional standards - Karnofsky performance status of 70% or greater. - Patients who have undergone a prior autologous transplantation are eligible for a reduced intensity transplant only Exclusion Criteria: Donor: - Donor unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing - Donor already enrolled on another investigational agent study - Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active Recipient: - Patient unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing - Patients with active, uncontrolled infection at the time of the transplant preparative regimen - Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active - Patients with a history of previous CNS tumor involvement showing active symptoms or signs along with documented disease on lumbar puncture and MRI of the brain within 30 days of start of conditioning - A condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of primary and secondary endpoints.

Additional Information

Official title A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies
Principal investigator Steve Devine, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Center for International Blood and Marrow Transplant Research.
Location data was received from the National Cancer Institute and was last updated in April 2016.