Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia</p>

Sponsor
Fred Hutchinson Cancer Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT00025545
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
79
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia.

PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

OBJECTIVES:
  • Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia.

  • Determine the kinetics and durability of engraftment after treatment with this regimen in these patients.

  • Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.

  • Determine the leukemia-free survival of patients treated with this regimen.

OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then undergo leukapheresis on days -1 and 0.

Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic peripheral blood stem cells on day 0.

PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
Study Start Date :
Mar 1, 1996
Actual Primary Completion Date :
Oct 1, 2002
Actual Study Completion Date :
Oct 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • One of the following diagnoses:

    • Primary acute leukemia beyond first remission

    • High-risk acute myelogenous leukemia

    • Acute lymphoblastic leukemia in first remission

    • Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles

    • No HLA-matched identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype

    • No leukoencephalopathy

    PATIENT CHARACTERISTICS:
    Age:
    • 55 and under
    Performance status:
    • Not specified
    Life expectancy:
    • Not specified
    Hematopoietic:
    • Not specified
    Hepatic:
    • SGOT no greater than 2 times normal

    • Hepatitis B surface antigen negative

    • No prior hepatitis C

    Renal:
    • No impaired renal function

    • Creatinine less than 2 times normal

    Cardiovascular:
    • No symptomatic cardiac disease
    Pulmonary:
    • No active pulmonary disease

    • DLCO at least 60% predicted

    Other:
    • HIV negative

    • No disease or other malignancy that severely limits life expectancy

    • No severe or life-threatening infection within the past 2 weeks

    • No history of septate fungal infection or disseminated candidiasis

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No prior bone marrow or peripheral blood stem cell transplantation
    Chemotherapy:
    • Not specified
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • No prior radiotherapy greater than 3,000 cGy to whole brain

    • No prior radiotherapy of 1,500 cGy to chest or abdomen

    • At least 6 months since prior involved-field radiotherapy to chest or abdomen

    Surgery:
    • Not specified

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States98109-1024

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Research Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Claudio Anasetti, MD, Fred Hutchinson Cancer Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00025545
    Other Study ID Numbers:
    • 1099.00
    • FHCRC-1099.00
    • NCI-H01-0078
    • CDR0000068972
    First Posted:
    Jun 20, 2003
    Last Update Posted:
    May 13, 2010
    Last Verified:
    May 1, 2010

    Study Results

    No Results Posted as of May 13, 2010