Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

March 31, 2001

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Leukemia
Interventions
DRUG

Imatinib Mesylate

600 mg by mouth on days 1 - 14 for course 1, and 600 mg by mouth daily days 1-14 (or daily if tolerated with course 1) for courses 2, 4, 6, 8.

DRUG

Cyclophosphamide

300 mg/m\^2 by vein every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m\^2) for courses 1, 3, 5, 7.

DRUG

Doxorubicin

50 mg/m\^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7.

DRUG

Vincristine

2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7.

DRUG

Dexamethasone

40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7.

DRUG

Methotrexate

"12 mg intrathecally (6 mg if via Ommaya reservoir) day 2 for courses 1, 3, 5, 7.~200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours on day 1 of courses 2, 4, 6, 8."

DRUG

Cytarabine

"100 mg intrathecally day 7 for courses 1, 3, 5, 7.~3 gm/m2 by vein over 2 hrs every 12 hrs for 4 doses on days 2 and 3 for courses 2, 4, 6, 8."

DRUG

Mesna

600 mg/m\^2 by vein daily for 24 hours for courses 1, 3, 5, 7.

DRUG

G-CSF

10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER