Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies

PHASE3CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

September 30, 2009

Conditions
Blood Stem Cell Transplant
Interventions
PROCEDURE

Blood stem cell versus bone marrow transplant

"1. Cyclophosphamide and Total Body Irradiation (CY-TBI)-based regimens that include at least 120 mg/kg cyclophosphamide and at least 1200 cGy of fractionated TBI.~2. Busulfan and cyclophosphamide (BU-CY)-based regimens that include at least 14 mg/kg busulfan orally or 11.2 mg/kg busulfan intravenously (14 x 0.8 correction factor) or a targeted busulfan dosing strategy aimed at a serum concentration greater than 600 ng/mL at steady state and at least 120 mg/kg cyclophosphamide.~3. Fludarabine and melphalan (Flu-Mel)-based regimens that include a fludarabine dose of least 120 mg per m2 and a melphalan dose of at least 140 mg per m2.~4. Fludarabine, busulfan, and ATG (Flu-Bu-ATG)-based regimens that include a fludarabine dose of at least 120 mg/m2, at least 8 mg/kg busulfan orally or 250 mg/m2 busulfan intravenously, and at least 40 mg/kg equine ATG or 4 mg/kg rabbit ATG. Institutional standards should be followed for targeting plasma levels."

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Marrow Donor Program

OTHER

collaborator

University of Minnesota

OTHER

collaborator

University of Florida

OTHER

collaborator

Duke University

OTHER

collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

lead

Mayo Clinic

OTHER

NCT00275678 - Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies | Biotech Hunter | Biotech Hunter