Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

March 5, 2013

Primary Completion Date

November 11, 2020

Study Completion Date

November 11, 2020

Conditions
Leukemia
Interventions
DRUG

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.

DRUG

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+).

DRUG

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

DRUG

Doxorubicin

50 mg/m2 by vein over 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7

DRUG

Mesna

600 mg/m2 by vein continuous infusion daily for 24 hours days 1-3 for courses 1, 3, 5, 7

DRUG

VSLI

2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7

DRUG

Solu-Medrol

40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Pegfilgrastim

6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.

DRUG

Dexamethasone

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

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01319981 - Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter