Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

November 30, 2010

Conditions
Hematopoietic/Lymphoid CancerAccelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult 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 LeukemiaBlastic Phase Chronic Myelogenous LeukemiaChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Chronic Myelogenous LeukemiaChildhood Myelodysplastic SyndromesChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous LeukemiaContiguous Stage II Adult Burkitt LymphomaContiguous Stage II Adult Diffuse Large Cell LymphomaContiguous Stage II Adult Diffuse Mixed Cell LymphomaContiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaContiguous Stage II Adult Immunoblastic Large Cell LymphomaContiguous Stage II Adult Lymphoblastic LymphomaContiguous Stage II Grade 1 Follicular LymphomaContiguous Stage II Grade 2 Follicular LymphomaContiguous Stage II Grade 3 Follicular LymphomaContiguous Stage II Mantle Cell LymphomaContiguous Stage II Marginal Zone LymphomaContiguous Stage II Small Lymphocytic Lymphomade Novo Myelodysplastic SyndromesEssential ThrombocythemiaExtramedullary PlasmacytomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueGraft Versus Host DiseaseIsolated Plasmacytoma of BoneJuvenile Myelomonocytic LeukemiaMeningeal Chronic Myelogenous LeukemiaMyelodysplastic/Myeloproliferative Disease, UnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaPreviously Treated Myelodysplastic SyndromesPrimary MyelofibrosisRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRelapsing Chronic Myelogenous LeukemiaSecondary Myelodysplastic SyndromesStage I Adult Burkitt LymphomaStage I Adult Diffuse Large Cell LymphomaStage I Adult Diffuse Mixed Cell LymphomaStage I Adult Diffuse Small Cleaved Cell LymphomaStage I Adult Hodgkin LymphomaStage I Adult Immunoblastic Large Cell LymphomaStage I Adult Lymphoblastic LymphomaStage I Adult T-cell Leukemia/LymphomaStage I Childhood Hodgkin LymphomaStage I Chronic Lymphocytic LeukemiaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Grade 3 Follicular LymphomaStage I Mantle Cell LymphomaStage I Marginal Zone LymphomaStage I Multiple MyelomaStage I Mycosis Fungoides/Sezary SyndromeStage I Small Lymphocytic LymphomaStage II Adult Hodgkin LymphomaStage II Adult T-cell Leukemia/LymphomaStage II Chronic Lymphocytic LeukemiaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Multiple MyelomaStage II Mycosis Fungoides/Sezary SyndromeStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Adult Hodgkin LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Adult T-cell Leukemia/LymphomaStage III Chronic Lymphocytic LeukemiaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Multiple MyelomaStage III Mycosis Fungoides/Sezary SyndromeStage III Small Lymphocytic LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Adult T-cell Leukemia/LymphomaStage IV Chronic Lymphocytic LeukemiaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Marginal Zone LymphomaStage IV Mycosis Fungoides/Sezary SyndromeStage IV Small Lymphocytic Lymphoma
Interventions
DRUG

beclomethasone dipropionate

Given orally

DRUG

placebo

Given orally

DRUG

tacrolimus

Given after transplant

DRUG

methotrexate

Given after transplant

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo stem cell transplant

Trial Locations (2)

98109

Fred Hutchinson Cancer Research Center, Seattle

07601

Hackensack University Medical Center, Hackensack

All Listed Sponsors
lead

Fred Hutchinson Cancer Center

OTHER

NCT00489203 - Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer | Biotech Hunter | Biotech Hunter