Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation.

PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for advanced hematologic cancer.

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following hematologic malignancies:

• Acute myeloid leukemia beyond first complete remission (CR1)

• Acute lymphoblastic leukemia beyond CR1

• Chronic myelogenous leukemia in second chronic phase, accelerated phase, or blastic phase

• Non-Hodgkin's lymphoma beyond CR2

• Hodgkin's lymphoma beyond CR2

• Multiple myeloma (any stage)

• Myelodysplastic syndromes beyond refractory anemia (including chronic myelomonocytic leukemia)

• Any refractory hematologic malignancy

• Advanced disease

• Scheduled for transplantation of mobilized allogeneic peripheral blood stem cells

• Genotypically HLA-identical stem cell donor available

PATIENT CHARACTERISTICS:

Age

• 65 and under

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT and SGPT ≤ 2.0 times ULN

Renal

• Creatinine clearance ≥ 60 mL/min

Pulmonary

• No acute pulmonary infection by chest x-ray

• No severe hypoxemia (partial O_2 < 70% of predicted) AND DLCO < 70% of predicted

• No mild hypoxemia (partial O_2 < 80% of predicted) AND DLCO < 60% of predicted

Other

• Not pregnant or nursing

• Negative pregnancy test

• No active systemic infection not controlled with antimicrobial therapy

• HIV negative (HIV-1 or other virus)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent T-cell depleted hematopoietic stem cell graft

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified