Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Lenograstim; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Phenytoin; Sargramostim; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a hematologic malignancy of 1 of the following high-risk types:

• Acute lymphoblastic leukemia

• Acute myeloid leukemia

• Chronic myelogenous leukemia

• Chronic lymphocytic leukemia

• Myelodysplastic syndromes

• Myeloproliferative disorder

• Multiple myeloma

• Plasma cell dyscrasias

• Non-Hodgkin lymphoma

• Hodgkin disease

PATIENT CHARACTERISTICS:

Performance status

• Karnofsky 50-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No liver failure

• No cirrhosis with evidence of portal hypertension

• No alcoholic hepatitis

• No esophageal varices

• No chronic hepatitis

• No other liver disease

Renal

• Not specified

Cardiovascular

• Left Ventricular Ejection Fraction (LVEF) > 35%

• No symptomatic coronary artery disease or cardiac failure requiring therapy

Pulmonary

• Diffusing capacity of lung for carbon monoxide (DLCO) > 30%

• Total lung capacity > 30%

• Forced expiratory volume in 1 second (FEV_1) > 30%

• No supplementary continuous oxygen

Other

• HIV negative

• No active nonhematologic malignancy except localized skin cancer

• No overt organ dysfunction

PRIOR CONCURRENT THERAPY:

• Not specified