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

NCT ID: NCT00038779

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-08-14

Study Completion Date

2004-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Leukemia Non Hodgkin's Lymphoma Aplastic Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Megadose T cell depleted

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DM96-122

Identifier Type: -

Identifier Source: org_study_id

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