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

This study has been terminated.
(Lack of Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038779
First received: June 5, 2002
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Leukemia
Non Hodgkin's Lymphoma
Aplastic Anemia
 Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 7
Study Start Date: August 1996
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Megadose T cell depleted Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038779

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038779     History of Changes
Other Study ID Numbers: DM96-122
Study First Received: June 5, 2002
Last Updated: August 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
CML
CLL
AML
 ALL
MDS
AA

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Pancytopenia
Hematologic Neoplasms
Hematologic Diseases
 Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013