NCT00067002 - Randomized Double Cord Blood Transplant Study | Biotech Hunter

Enrollment

110

Participants

Timeline

Start Date

April 30, 2003

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions

Leukemia, Lymphocytic, AcuteLeukemia, Myelocytic, AcuteLeukemia, Myeloid, ChronicLymphoma, Non-Hodgkin

Interventions

PROCEDURE

Expanded allogeneic cord blood (CB)

Transplantation of Two Unmanipulated Cord Blood Units.

PROCEDURE

One Unmanipulated and One Expanded Cord Blood Unit

Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.

DRUG

Rituxan

375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.

DRUG

Melphalan

140 mg/m2 by vein on Day -8.

DRUG

Thiotepa

5 mg/Kg by vein on Day -7.

DRUG

Fludarabine

40 mg/m2 by vein on Days -6 to -3.

DRUG

Cyclophosphamide

50 mg/kg by vein on Day -6.

DRUG

Mesna

10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).

RADIATION

Total body irradiation (TBI)

Total body irradiation (TBI) given on Day -1 at 2 Gy.

Trial Locations (1)

University of Texas MD Anderson Cancer Center, Houston