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

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 64
Study Start Date: May 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Related donors receiving plerixafor Drug: Plerixafor
Other Names:
  • Mozobil
  • AMD3000

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696461

Contacts
Contact: Laurie Spiess 612-884-8787 lspiess2@nmdp.org

Locations
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States
Contact: Hugo Fernandez, MD       hugo.fernandez@moffitt.org   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States
Contact: Ned Waller, MD       ewaller@emory.edu   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
Contact: Andrew Artz, MD       aartz@medicine.bsd.uchicago.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Yi Bin Chen, MD       ychen6@partners.org   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States
Contact: Brian McClune, DO       bmcclune@umn.edu   
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Mark Litzow, MD       litzow.mark@mayo.edu   
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States
Contact: John DiPersio, MD       jdipersi@im.wustl.edu   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States
Contact: Mitch Horwitz, MD       mitchell.horwitz@duke.edu   
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States
Contact: Ed Copelan, MD       copelae@ccf.org   
Ohio State University Recruiting
Columbus, Ohio, United States
Contact: Steve Devine, MD       steven.devine@osumc.edu   
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States
Contact: Michael Craig, MD       craigm@wvuhealthcare.com   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States
Contact: Mehdi Hamadani, MD       mhamadani@mcw.edu   
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Genzyme, a Sanofi Company
Sanofi
Investigators
Principal Investigator: Steve Devine, MD Ohio State University
  More Information

No publications provided

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01696461     History of Changes
Other Study ID Numbers: 09-PLEX
Study First Received: September 24, 2012
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014