31
Participants
Start Date
March 5, 2013
Primary Completion Date
November 11, 2020
Study Completion Date
November 11, 2020
Rituximab
In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Imatinib
600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Cyclophosphamide
300 mg/m2 by vein over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
Doxorubicin
50 mg/m2 by vein over 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Mesna
600 mg/m2 by vein continuous infusion daily for 24 hours days 1-3 for courses 1, 3, 5, 7
VSLI
2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Solu-Medrol
40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Methotrexate
200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
Ara-C
3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
G-CSF
10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.
Pegfilgrastim
6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Dexamethasone
40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
University of Texas MD Anderson Cancer Center, Houston
Spectrum Pharmaceuticals, Inc
INDUSTRY
M.D. Anderson Cancer Center
OTHER