S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid

Criteria

DISEASE CHARACTERISTICS:

• Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis) OR

• Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic therapy)

• Must have A1 marrow, B1 blood, and C1 extramedullary disease status

• Must have received prior remission induction chemotherapy

• Must have a genotypically HLA-identical sibling donor available that is not a monozygotic identical twin

• No M3 AML or blastic transformation of chronic myelogenous leukemia

• If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7 days

• Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910

PATIENT CHARACTERISTICS:

Age

• 55 to 69

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other malignancy within the past 2 years except for the following:

• Adequately treated basal cell or squamous cell skin cancer

• Carcinoma in situ of the cervix

• Adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior allogeneic hematopoietic stem cell transplantation

Chemotherapy

• See Disease Characteristics

• Prior consolidation therapy allowed

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Prior organ transplantation allowed provided not concurrently receiving immunosuppressive therapy