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.

Condition	Treatment or Intervention	Phase
childhood Hodgkin's lymphoma childhood non-Hodgkin's lymphoma Graft Versus Host Disease hematopoietic and lymphoid cancer	Drug: mycophenolate mofetil  Drug: tacrolimus  Procedure: biological response modifier therapy  Procedure: complications of therapy assessment/management  Procedure: graft versus host disease prophylaxis/therapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute graft-vs-host disease in patients with advanced hematologic malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Secondary

• Determine the safety of this regimen in these patients.

OUTLINE: This is a non-randomized study.

Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 60 followed by a taper to day 180. Patients also receive mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-60 followed by a taper to day 180. Treatment is discontinued at day 180 in the absence of graft-vs-host disease.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.

Ages Eligible for Study:  up to  65 Years,  Genders Eligible for Study:  Both

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

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States; Recruiting

Study chairs or principal investigators

Richard Nash, MD,  Principal Investigator,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000391026; FHCRC-1893.00; NCT00096096
Record last reviewed:  October 2004
Last Updated:  February 24, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00096096
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08