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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease

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

Intervention / Treatment
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* Drug: mycophenolate mofetil
* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mycophenolate mofetil|nan|
|Drug: tacrolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Area under the curve of plasma mycophenolic acid |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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graft versus host disease, accelerated phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent adult Burkitt lymphoma, chronic idiopathic myelofibrosis, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent mantle cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult lymphoblastic lymphoma, secondary acute myeloid leukemia, secondary myelodysplastic syndromes, adult acute lymphoblastic leukemia in remission, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, chronic myelomonocytic leukemia, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory hairy cell leukemia, juvenile myelomonocytic leukemia, chronic eosinophilic leukemia, chronic neutrophilic leukemia, chronic phase chronic myelogenous leukemia, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, recurrent/refractory childhood Hodgkin lymphoma, recurrent mycosis fungoides/Sezary syndrome, refractory chronic lymphocytic leukemia, refractory cytopenia with multilineage dysplasia, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, adult acute myeloid leukemia in remission, childhood acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), childhood acute lymphoblastic leukemia in remission, childhood chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, myelodysplastic/myeloproliferative disease, unclassifiable, nodal marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, splenic marginal zone lymphoma, atypical chronic myeloid leukemia, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, childhood myelodysplastic syndromes