NCT00089011 - Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer | Biotech Hunter

Enrollment

150

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

March 31, 2014

Study Completion Date

July 31, 2018

Conditions

Accelerated 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 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 Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaBlastic Phase Chronic Myelogenous LeukemiaChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Burkitt LymphomaChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaChildhood Immunoblastic Large Cell LymphomaChildhood Myelodysplastic SyndromesChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic 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 LymphomaCutaneous B-cell Non-Hodgkin Lymphomade Novo Myelodysplastic SyndromesEssential ThrombocythemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaIntraocular LymphomaNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed 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 LymphomaNoncutaneous Extranodal LymphomaPeripheral T-cell LymphomaPolycythemia VeraPost-transplant Lymphoproliferative DisorderPreviously Treated Myelodysplastic SyndromesPrimary MyelofibrosisProlymphocytic LeukemiaRecurrent 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 Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell 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 LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSmall Intestine LymphomaSplenic Marginal Zone LymphomaStage 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 Immunoblastic Large Cell LymphomaStage I Adult Lymphoblastic LymphomaStage I Adult T-cell Leukemia/LymphomaStage I Childhood Anaplastic Large Cell LymphomaStage I Childhood Large Cell LymphomaStage I Childhood Lymphoblastic LymphomaStage I Childhood Small Noncleaved Cell 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 Small Lymphocytic LymphomaStage IA Mycosis Fungoides/Sezary SyndromeStage IB Mycosis Fungoides/Sezary SyndromeStage II Adult T-cell Leukemia/LymphomaStage II Childhood Anaplastic Large Cell LymphomaStage II Childhood Large Cell LymphomaStage II Childhood Lymphoblastic LymphomaStage II Childhood Small Noncleaved Cell LymphomaStage II Chronic Lymphocytic LeukemiaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Multiple MyelomaStage IIA Mycosis Fungoides/Sezary SyndromeStage IIB 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 Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Adult T-cell Leukemia/LymphomaStage III Childhood Anaplastic Large Cell LymphomaStage III Childhood Large Cell LymphomaStage III Childhood Lymphoblastic LymphomaStage III Childhood Small Noncleaved Cell 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 Small Lymphocytic LymphomaStage IIIA Mycosis Fungoides/Sezary SyndromeStage IIIB Mycosis Fungoides/Sezary SyndromeStage 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 Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Adult T-cell Leukemia/LymphomaStage IV Childhood Anaplastic Large Cell LymphomaStage IV Childhood Large Cell LymphomaStage IV Childhood Lymphoblastic LymphomaStage IV Childhood Small Noncleaved Cell 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 Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Small Lymphocytic LymphomaStage IVA Mycosis Fungoides/Sezary SyndromeStage IVB Mycosis Fungoides/Sezary SyndromeTesticular LymphomaUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid LeukemiaUntreated Childhood Acute Lymphoblastic LeukemiaUntreated Childhood Acute Myeloid Leukemia and Other Myeloid MalignanciesWaldenström Macroglobulinemia

Interventions

DRUG

fludarabine phosphate

Given IV

RADIATION

total-body irradiation

Undergo radiotherapy

DRUG

mycophenolate mofetil

Given IV or PO

DRUG

tacrolimus

Given IV or PO

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic peripheral blood stem cell transplant

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo allogeneic peripheral blood stem cell transplant

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (5)

10126

University of Torino, Torino

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

98101

VA Puget Sound Health Care System, Seattle

98109

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

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER