Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
NCT00027547 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2011-11-30
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and donor white blood cells may prevent this from happening.
PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia.
Conditions
Interventions
- BIOLOGICAL
-
therapeutic allogeneic lymphocytes
- DRUG
-
cyclosporine
- DRUG
- DRUG
-
fludarabine phosphate
- DRUG
-
methotrexate
- DRUG
-
mycophenolate mofetil
- PROCEDURE
-
allogeneic bone marrow transplantation
- PROCEDURE
-
peripheral blood stem cell transplantation
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
George Georges, MD · Fred Hutchinson Cancer Center
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-07-31
- Completion
- 2004-07-31
Countries
- United States
- Germany
Study Locations
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