Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 30, 2001

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Adult 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 LymphomaChildhood Burkitt LymphomaChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaChildhood Immunoblastic Large Cell LymphomaChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic Phase Chronic Myelogenous LeukemiaContiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaContiguous Stage II Grade 1 Follicular LymphomaContiguous Stage II Grade 2 Follicular LymphomaContiguous Stage II Marginal Zone LymphomaContiguous Stage II Small Lymphocytic LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaPeripheral T-cell LymphomaPreviously Treated Myelodysplastic SyndromesProgressive Hairy Cell Leukemia, Initial TreatmentRecurrent 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 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 LeukemiaSplenic Marginal Zone LymphomaStage I Adult Diffuse Small Cleaved Cell LymphomaStage I Childhood Anaplastic Large Cell LymphomaStage I Childhood Large Cell LymphomaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Mantle Cell LymphomaStage I Marginal Zone LymphomaStage I Mycosis Fungoides/Sezary SyndromeStage I Small Lymphocytic LymphomaStage II Childhood Anaplastic Large Cell LymphomaStage II Childhood Large Cell LymphomaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Mycosis Fungoides/Sezary SyndromeStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Childhood Anaplastic Large Cell LymphomaStage III Childhood Large Cell LymphomaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Mycosis Fungoides/Sezary SyndromeStage III Small Lymphocytic LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Childhood Anaplastic Large Cell LymphomaStage IV Childhood Large Cell LymphomaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Mycosis Fungoides/Sezary SyndromeStage IV Small Lymphocytic LymphomaT-cell Large Granular Lymphocyte LeukemiaWaldenström Macroglobulinemia
Interventions
BIOLOGICAL

alemtuzumab

Given IV

DRUG

fludarabine phosphate

Given IV

RADIATION

total-body irradiation

Undergo TBI

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic HSCT

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic peripheral blood stem cell transplantation

DRUG

mycophenolate mofetil

Given PO

DRUG

cyclosporine

Given IV or PO

Trial Locations (7)

10126

University of Torino, Torino

53226

Froedtert Memorial Lutheran Hospital, 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

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 Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER

NCT00040846 - Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies | Biotech Hunter | Biotech Hunter