Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00038779
Collaborator
(none)
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Study Details

Study Description

Brief Summary

The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States
Actual Study Start Date :
Aug 14, 1996
Actual Primary Completion Date :
Sep 20, 2004
Actual Study Completion Date :
Sep 20, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Megadose T cell depleted

Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.

    • Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.

    • Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.

    • Patients must be <age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor.

    • Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%.

    • Patients with serious intercurrent medical illness are not eligible.

    • Patients and their donors must provide written informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00038779
    Other Study ID Numbers:
    • DM96-122
    First Posted:
    Jun 7, 2002
    Last Update Posted:
    Oct 30, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 30, 2018