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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014