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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00038779
Other study ID # DM96-122
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 14, 1996
Est. completion date September 20, 2004

Study information

Verified date October 2018
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date September 20, 2004
Est. primary completion date September 20, 2004
Accepts healthy volunteers No
Gender All
Age group N/A to 49 Years
Eligibility - 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.

Study Design


Intervention

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


Locations

Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

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