Non Hodgkin Lymphoma Clinical Trial
Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
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.
Full Description
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Seattle Washington, 98109, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.