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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
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

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

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

Outcome Description:

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.

Outcome Time Frame:

donation

Safety Issue:

No

Principal Investigator

Steve Devine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

09-PLEX

NCT ID:

NCT01696461

Start Date:

May 2013

Completion Date:

September 2016

Related Keywords:

  • 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
  • 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

Name

Location

Mayo ClinicRochester, Minnesota  55905
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of MinnesotaMinneapolis, Minnesota  55455
Duke UniversityDurham, North Carolina  27710
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Emory UniversityAtlanta, Georgia  30322
Cleveland ClinicCleveland, Ohio  44195
Ohio State UniversityColumbus, Ohio  43210
University of ChicagoChicago, Illinois  60637
Washington UniversitySt. Louis, Missouri  63110
West Virginia UniversityMorgantown, West Virginia  26506