Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
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Keep this study
Lead
Fred Hutchinson Cancer Center
With
National Cancer Institute (NCI)
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.
Age
0–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
Clareo Health | Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
