NCT00322101 - Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

April 30, 2012

Study Completion Date

October 31, 2014

Conditions

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAcute Myeloid Leukemia/Transient Myeloproliferative DisorderAdult 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)Childhood Acute Myeloid Leukemia in RemissionChildhood Myelodysplastic Syndromesde Novo Myelodysplastic SyndromesMyelodysplastic Syndrome With Isolated Del(5q)Myelodysplastic/Myeloproliferative Neoplasm, UnclassifiablePreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Myeloid LeukemiaRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic Syndromes

Interventions

RADIATION

total-body irradiation

Radiation

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic transplantation

DRUG

cyclophosphamide

Given IV

DRUG

mycophenolate mofetil

Given orally

DRUG

busulfan

Given IV or orally

DRUG

cyclosporine

Given IV or orally

DRUG

fludarabine phosphate

Given IV

PROCEDURE

peripheral blood stem cell transplantation

Undergo transplantation

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo allogeneic transplantation

OTHER

laboratory biomarker analysis

Correlative studies

GENETIC

cytogenetic analysis

Correlative studies

OTHER

flow cytometry

Correlative studies

GENETIC

fluorescence in situ hybridization

Correlative studies

OTHER

pharmacological study

Correlative studies

GENETIC

polymorphism analysis

Correlative studies

DRUG

tacrolimus

Given IV or orally

DRUG

methotrexate

Given IV

Trial Locations (8)

10021

Weill Cornell University, New York

30322

Emory University, Altanta

84112

University of Utah, Salt Lake City

98108

Veterans Administration Center-Seattle, Seattle

98109

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

Unknown

HealthOne Presbyterian St. Lukes Medical Center, Denver

Medical College Wisconsin, Milwaukee

01307

Technical University Dresden, Dresden

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER