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

Fred Hutchinson Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

Interventions

mycophenolate mofetilDRUG

tacrolimusDRUG

Eligibility

Sex: ALLMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Efficacy

Secondary Outcomes

Safety

Area under the curve of plasma mycophenolic acid

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.