Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies
NCT01789255 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2018-07-24
Summary
This pilot phase II trial studies how well giving vorinostat, tacrolimus, and methotrexate works in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients with hematological malignancies. Vorinostat, tacrolimus, and methotrexate may be an effective treatment for GVHD caused by a bone marrow transplant.
Conditions
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- 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)
- Adult Grade III Lymphomatoid Granulomatosis
- B-cell Chronic Lymphocytic Leukemia
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Chronic Myelomonocytic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- Contiguous Stage II Adult Burkitt Lymphoma
- Contiguous Stage II Adult Diffuse Large Cell Lymphoma
- Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Contiguous Stage II Adult Lymphoblastic Lymphoma
- Contiguous Stage II Grade 1 Follicular Lymphoma
- Contiguous Stage II Grade 2 Follicular Lymphoma
- Contiguous Stage II Grade 3 Follicular Lymphoma
- Contiguous Stage II Mantle Cell Lymphoma
- Contiguous Stage II Marginal Zone Lymphoma
- Contiguous Stage II Small Lymphocytic Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Graft Versus Host Disease
- Intraocular Lymphoma
- Myelodysplastic Syndrome With Isolated Del(5q)
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell Lymphoma
- Noncontiguous Stage II Adult Burkitt Lymphoma
- Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Noncontiguous Stage II Grade 1 Follicular Lymphoma
- Noncontiguous Stage II Grade 2 Follicular Lymphoma
- Noncontiguous Stage II Grade 3 Follicular Lymphoma
- Noncontiguous Stage II Mantle Cell Lymphoma
- Noncontiguous Stage II Marginal Zone Lymphoma
- Noncontiguous Stage II Small Lymphocytic Lymphoma
- Post-transplant Lymphoproliferative Disorder
- Primary Central Nervous System Hodgkin Lymphoma
- Primary Central Nervous System Non-Hodgkin Lymphoma
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Refractory Anemia
- Refractory Anemia With Excess Blasts
- Refractory Anemia With Ringed Sideroblasts
- Refractory Chronic Lymphocytic Leukemia
- Refractory Cytopenia With Multilineage Dysplasia
- Refractory Hairy Cell Leukemia
- Relapsing Chronic Myelogenous Leukemia
- Secondary Central Nervous System Hodgkin Lymphoma
- Secondary Central Nervous System Non-Hodgkin Lymphoma
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Stage I Adult Burkitt Lymphoma
- Stage I Adult Diffuse Large Cell Lymphoma
- Stage I Adult Diffuse Mixed Cell Lymphoma
- Stage I Adult Diffuse Small Cleaved Cell Lymphoma
- Stage I Adult Hodgkin Lymphoma
- Stage I Adult Immunoblastic Large Cell Lymphoma
- Stage I Adult Lymphoblastic Lymphoma
- Stage I Chronic Lymphocytic Leukemia
- Stage I Grade 1 Follicular Lymphoma
- Stage I Grade 2 Follicular Lymphoma
- Stage I Grade 3 Follicular Lymphoma
- Stage I Mantle Cell Lymphoma
- Stage I Marginal Zone Lymphoma
- Stage I Small Lymphocytic Lymphoma
- Stage II Adult Hodgkin Lymphoma
- Stage II 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 Hodgkin Lymphoma
- Stage III Adult Immunoblastic Large Cell Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Chronic Lymphocytic Leukemia
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone 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 Hodgkin Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Chronic Lymphocytic Leukemia
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Small Lymphocytic Lymphoma
- Testicular Lymphoma
- Waldenström Macroglobulinemia
Interventions
- DRUG
-
vorinostat
Given PO
- DRUG
-
Given IV or PO
- DRUG
-
cyclosporine
Given IV or PO
- DRUG
-
methotrexate
Given IV
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
pharmacological study
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Pavan Reddy · University of Michigan University Hospital
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2014-03-31
- Completion
- 2014-03-31
Countries
- United States
Study Locations
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