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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Terminated

Conditions

Aplastic Anemia
Leukemia
Non Hodgkin's Lymphoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00038779
DM96-122

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

Under 49 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Megadose T cell depleted
Experimental group
Treatment:
Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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