Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
NCT00489203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2021-02-03
Summary
RATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host disease in patients undergoing a stem cell transplant for hematologic cancer.
PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell transplant for hematologic cancer.
Conditions
- Hematopoietic/Lymphoid Cancer
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult 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)
- Atypical Chronic Myeloid Leukemia
- Blastic Phase Chronic Myelogenous Leukemia
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Chronic Myelogenous Leukemia
- Childhood Myelodysplastic Syndromes
- Chronic Eosinophilic Leukemia
- Chronic Myelomonocytic Leukemia
- Chronic Neutrophilic 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
- de Novo Myelodysplastic Syndromes
- Essential Thrombocythemia
- Extramedullary Plasmacytoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Graft Versus Host Disease
- Isolated Plasmacytoma of Bone
- Juvenile Myelomonocytic Leukemia
- Meningeal Chronic Myelogenous Leukemia
- Myelodysplastic/Myeloproliferative Disease, 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 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
- Previously Treated Myelodysplastic Syndromes
- Primary Myelofibrosis
- Recurrent Adult Acute Lymphoblastic Leukemia
- 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 Lymphoblastic Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin 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 Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Hairy Cell Leukemia
- Relapsing Chronic Myelogenous Leukemia
- Secondary Myelodysplastic Syndromes
- 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 Adult T-cell Leukemia/Lymphoma
- Stage I Childhood Hodgkin Lymphoma
- Stage I Chronic Lymphocytic Leukemia
- Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
- 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 Multiple Myeloma
- Stage I Mycosis Fungoides/Sezary Syndrome
- Stage I Small Lymphocytic Lymphoma
- Stage II Adult Hodgkin Lymphoma
- Stage II Adult T-cell Leukemia/Lymphoma
- Stage II Chronic Lymphocytic Leukemia
- Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage II Multiple Myeloma
- Stage II Mycosis Fungoides/Sezary Syndrome
- 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 Adult T-cell Leukemia/Lymphoma
- Stage III Chronic Lymphocytic Leukemia
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- 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 III Multiple Myeloma
- Stage III Mycosis Fungoides/Sezary Syndrome
- Stage III Small Lymphocytic 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 Adult T-cell Leukemia/Lymphoma
- Stage IV Chronic Lymphocytic Leukemia
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Mycosis Fungoides/Sezary Syndrome
- Stage IV Small Lymphocytic Lymphoma
Interventions
- DRUG
-
beclomethasone dipropionate
Given orally
- DRUG
-
Given orally
- DRUG
-
Given after transplant
- DRUG
-
methotrexate
Given after transplant
- PROCEDURE
-
allogeneic hematopoietic stem cell transplantation
Undergo stem cell transplant
Sponsors & Collaborators
-
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Paul Martin · Fred Hutchinson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2010-11-30
Countries
- United States
Study Locations
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