NCT00671658 - Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia | Biotech Hunter

Enrollment

220

Participants

Timeline

Start Date

November 30, 2002

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions

LeukemiaAcute Lymphoblastic Leukemia

Interventions

DRUG

Rituximab

375 mg/m2 by vein

DRUG

Cyclophosphamide (CTX)

300 mg/m2 by vein

DRUG

Doxorubicin

50 mg/m2 by vein

DRUG

Vincristine

2 mg by vein

DRUG

Dexamethasone

40 mg by vein or by mouth (P.O.)

DRUG

Methotrexate (MTX)

"12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7~200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8"

DRUG

Cytarabine

"100 mg intrathecal for Courses 1,3,5,7~3 gm/m2 by vein for Courses 2,4,6,8"

DRUG

G-CSF

10 ug/kg subcutaneous injection

DRUG

Mesna

600 mg/m2 a day by vein

DRUG

Pegylated asparaginase

2000 International units/m2 by vein

DRUG

Pegfilgrastim

6 mg (flat dose) within 72 hrs after completion of chemotherapy

DRUG

Solumedrol

40 mg by vein for Courses 2,4,6,8

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

All Listed Sponsors

lead

M.D. Anderson Cancer Center

OTHER