Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

May 31, 2011

Study Completion Date

May 8, 2015

Conditions
Myelodysplastic/Myeloproliferative Neoplasm, UnclassifiablePreviously Treated Myelodysplastic SyndromeRefractory Chronic Lymphocytic LeukemiaRefractory Plasma Cell MyelomaWaldenstrom MacroglobulinemiaAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLLAdult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARAAdult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1Atypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Burkitt LymphomaChildhood Chronic Myelogenous Leukemia, BCR-ABL1 PositiveChildhood Diffuse Large Cell LymphomaChildhood Immunoblastic LymphomaChildhood Myelodysplastic SyndromeStage II Contiguous Adult Burkitt LymphomaStage II Contiguous Adult Diffuse Large Cell LymphomaStage II Contiguous Adult Diffuse Mixed Cell LymphomaStage II Contiguous Adult Diffuse Small Cleaved Cell LymphomaStage II Adult Contiguous Immunoblastic LymphomaStage II Contiguous Adult Lymphoblastic LymphomaStage II Grade 1 Contiguous Follicular LymphomaStage II Grade 2 Contiguous Follicular LymphomaStage II Grade 3 Contiguous Follicular LymphomaStage II Contiguous Mantle Cell LymphomaStage II Non-Contiguous Adult Burkitt LymphomaStage II Non-Contiguous Adult Diffuse Large Cell LymphomaStage II Non-Contiguous Adult Diffuse Mixed Cell LymphomaStage II Non-Contiguous Adult Diffuse Small Cleaved Cell LymphomaStage II Adult Non-Contiguous Immunoblastic LymphomaStage II Non-Contiguous Adult Lymphoblastic LymphomaStage II Grade 1 Non-Contiguous Follicular LymphomaStage II Grade 2 Non-Contiguous Follicular LymphomaStage II Grade 3 Non-Contiguous Follicular LymphomaStage II Non-Contiguous Mantle Cell LymphomaStage II Small Lymphocytic LymphomaRecurrent 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 Hodgkin LymphomaRecurrent Adult Immunoblastic LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Burkitt LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic LymphomaRecurrent Childhood Hodgkin LymphomaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 PositiveSecondary Myelodysplastic SyndromeStage I Adult Burkitt LymphomaStage I Adult Diffuse Large Cell LymphomaStage I Adult Diffuse Mixed Cell LymphomaStage I Adult Immunoblastic LymphomaStage I Adult Lymphoblastic LymphomaStage I Childhood Anaplastic Large Cell LymphomaStage I Childhood Large Cell LymphomaStage I Childhood Lymphoblastic LymphomaStage I Childhood Burkitt 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 Small Lymphocytic LymphomaStage II Childhood Anaplastic Large Cell LymphomaStage II Childhood Lymphoblastic LymphomaStage II Childhood Burkitt LymphomaStage 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 Immunoblastic LymphomaStage III Adult Lymphoblastic LymphomaStage III Childhood Anaplastic Large Cell LymphomaStage III Childhood Large Cell LymphomaStage III Childhood Lymphoblastic LymphomaStage III Childhood Burkitt 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 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 Immunoblastic LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Childhood Anaplastic Large Cell LymphomaStage IV Childhood Large Cell LymphomaStage IV Childhood Lymphoblastic LymphomaStage IV Childhood Burkitt LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Small Lymphocytic Lymphoma
Interventions
DRUG

Fludarabine Phosphate

Given IV

RADIATION

Total-Body Irradiation

Undergo total-body irradiation

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplantation

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplantation

DRUG

Tacrolimus

Given IV or PO

DRUG

Mycophenolate Mofetil

Given PO

DRUG

Sirolimus

Given PO

Trial Locations (11)

2100

Rigshospitalet University Hospital, Copenhagen

30322

Emory University/Winship Cancer Institute, Atlanta

50924

Medizinische Univ Klinik Koln, Cologne

53226

Froedtert and the Medical College of Wisconsin, Milwaukee

80218

Presbyterian - Saint Lukes Medical Center - Health One, Denver

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

98108

Veterans Administration Center-Seattle, Seattle

98109

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle

D-04103

Universitaet Leipzig, Leipzig

D-72076

University of Tuebingen-Germany, Tübingen

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER

NCT00105001 - Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer | Biotech Hunter | Biotech Hunter