NCT00008177 - Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 27, 1999

Primary Completion Date

March 21, 2009

Study Completion Date

December 15, 2010

Conditions

Adult 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)Chronic Myelomonocytic Leukemiade Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Myeloid LeukemiaRefractory Anemia With Excess BlastsRefractory Anemia With Excess Blasts in TransformationRefractory Anemia With Ringed SideroblastsRefractory Cytopenia With Multilineage DysplasiaSecondary Myelodysplastic SyndromesUntreated Adult Acute Myeloid Leukemia

Interventions

RADIATION

iodine I 131 monoclonal antibody BC8

Given IV

RADIATION

total-body irradiation

Undergo total-body irradiation

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic peripheral blood stem cell transplantation

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic peripheral blood stem cell transplantation

DRUG

fludarabine phosphate

Given IV

DRUG

cyclosporine

Given orally or IV

DRUG

mycophenolate mofetil

Given orally or IV

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (1)

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