A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
Phase 2
N/A
65 Years
N/A
65 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Efficacy
Principal Investigator
Richard Nash, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1893.00
NCT ID:
NCT00096096
Start Date:
August 2004
Completion Date:
Related Keywords:
- Chronic Myeloproliferative Disorders
- Graft Versus Host Disease
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- 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
- Neoplasms
- Graft vs Host Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Lymphoma, Large-Cell, Immunoblastic
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
