A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Center for International Blood and Marrow Transplant Research
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Sanofi
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT01696461
First received: September 24, 2012
Last updated: February 4, 2014
Last verified: February 2014

September 24, 2012
February 4, 2014
May 2013
September 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
To determine 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. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections. All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.
Same as current
Complete list of historical versions of study NCT01696461 on ClinicalTrials.gov Archive Site
  • incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor [ Time Frame: baseline, donation ] [ Designated as safety issue: Yes ]
    To ascertain the incidence and severity of acute toxicities before and during apheresis experienced by donors receiving plerixafor
  • 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 ] [ Designated as safety issue: Yes ]
    To characterize the adverse effects experienced by donors receiving plerixafor up to one year post donation
  • 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 ] [ Designated as safety issue: Yes ]
    To determine the incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with plerixafor
  • Description of T-cell (CD3+) and myeloid (CD33+) chimerism after transplantation of hematopoietic cells mobilized with plerixafor [ Time Frame: Day 28, 100, 180, 365 ] [ Designated as safety issue: No ]
    To describe T-cell (CD3+) and myeloid (CD33+) chimerism after transplantation of hematopoietic cells mobilized with plerixafor
  • 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 ] [ Designated as safety issue: Yes ]
    To determine the incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with plerixafor
  • 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 ] [ Designated as safety issue: Yes ]
    To determine the incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with plerixafor
  • 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 ] [ Designated as safety issue: Yes ]
    To assess the rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with plerixafor
  • incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with plerixafor in CMV seropositive recipients [ Time Frame: Day 100, 180, 365 ] [ Designated as safety issue: Yes ]
    To determine the incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with plerixafor in CMV seropositive recipients
  • 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 ] [ Designated as safety issue: Yes ]
    To determine the incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with plerixafor
  • 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 ] [ Designated as safety issue: Yes ]
    To determine the probability of progression-free and overall survival after transplantation of hematopoietic cells mobilized with plerixafor
  • describe the cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/NK-cells) [ Time Frame: donation ] [ Designated as safety issue: No ]
    To describe the cellular composition of allografts mobilized with plerixafor (stem/progenitor cells, T/B/NK-cells)
Same as current
Not Provided
Not Provided
 
A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Drug: Plerixafor
Other Names:
  • Mozobil
  • AMD3000
Experimental: Related donors receiving plerixafor
Intervention: Drug: Plerixafor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
September 2016
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Laurie Spiess 612-884-8787 lspiess2@nmdp.org
United States
 
NCT01696461
09-PLEX
Yes
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
  • Genzyme, a Sanofi Company
  • Sanofi
Principal Investigator: Steve Devine, MD Ohio State University
Center for International Blood and Marrow Transplant Research
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP