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

This study has been terminated.

First Received: June 5, 2002 Last Updated: June 23, 2005 History of Changes

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038779

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

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Megadose T-Cell Depleted HLA-Nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

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

Estimated Enrollment:	42
Study Start Date:	August 1996

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

Study ID Numbers:	DM96-122
Study First Received:	June 5, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00038779 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Lymphoma
CML
CLL
AML

ALL
MDS
AA

Study placed in the following topic categories:

Immunoproliferative Disorders
Hematologic Neoplasms
Aplastic Anemia
Hematologic Diseases
Anemia
Pancytopenia
Lymphoma, Small Cleaved-cell, Diffuse

Leukemia
Lymphatic Diseases
Anemia, Aplastic
Lymphoma, Non-Hodgkin
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Neoplasms
Hematologic Diseases
Anemia
Pancytopenia
Leukemia

Lymphatic Diseases
Neoplasms
Neoplasms by Site
Anemia, Aplastic
Lymphoma, Non-Hodgkin
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009