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

Back to results

Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Lymphoma, CML, CLL, AML, ALL, MDS, AA

Eligibility Criteria

undefined - 49 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Megadose T cell depleted

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00038779

First Posted

June 5, 2002

Last Updated

October 29, 2018

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00038779

Brief Title

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

Official Title

Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

Lack of Accrual

Study Start Date

August 14, 1996 (Actual)

Primary Completion Date

September 20, 2004 (Actual)

Study Completion Date

September 20, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Non Hodgkin's Lymphoma, Aplastic Anemia

Keywords

Lymphoma, CML, CLL, AML, ALL, MDS, AA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Megadose T cell depleted

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Leukemia, Non Hodgkin's Lymphoma, Aplastic Anemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial