Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

September 30, 2003

Primary Completion Date

January 31, 2006

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 Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Burkitt LymphomaChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic Large Cell LymphomaChildhood Myelodysplastic SyndromesChildhood Nasal Type Extranodal NK/T-cell LymphomaChildhood Renal Cell CarcinomaChronic Myelomonocytic LeukemiaChronic Phase Chronic Myelogenous LeukemiaClear Cell Renal Cell CarcinomaContiguous Stage II Adult Burkitt LymphomaContiguous Stage II Adult Diffuse Large Cell LymphomaContiguous Stage II Adult Diffuse Mixed Cell LymphomaContiguous Stage II Adult Immunoblastic Large Cell LymphomaContiguous Stage II Adult Lymphoblastic LymphomaContiguous Stage II Grade 3 Follicular LymphomaContiguous Stage II Mantle Cell Lymphomade Novo Myelodysplastic SyndromesExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaJuvenile Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal 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 Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncutaneous Extranodal LymphomaPeripheral T-cell LymphomaPost-transplant Lymphoproliferative DisorderPreviously Treated Myelodysplastic SyndromesRecurrent 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 Renal Cell CancerRecurrent Small Lymphocytic LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaRefractory AnemiaRefractory Anemia With Ringed SideroblastsRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSplenic Marginal Zone LymphomaStage I Adult Burkitt LymphomaStage I Adult Diffuse Large Cell LymphomaStage I Adult Diffuse Mixed 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 Grade 3 Follicular LymphomaStage I Mantle Cell LymphomaStage 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 III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed 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 Grade 3 Follicular LymphomaStage III Mantle Cell LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed 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 Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Renal Cell CancerT-cell Large Granular Lymphocyte LeukemiaType 1 Papillary Renal Cell CarcinomaType 2 Papillary Renal Cell CarcinomaUntreated 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 TBI

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo allogeneic PBMC transplantation

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic PBMC transplantation

DRUG

cyclosporine

Given PO

DRUG

mycophenolate mofetil

Given PO or IV

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (10)

10126

University of Torino, Torino

30322

Emory University/Winship Cancer Institute, Atlanta

53226

Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin, Milwaukee

80218

Rocky Mountain Cancer Centers-Midtown, Denver

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

94305

Stanford University Hospitals and Clinics, Stanford

97239

OHSU Knight Cancer Institute, Portland

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 Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER

NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant | Biotech Hunter | Biotech Hunter