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

Summary

The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Naval Daver, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-03-31

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• United States

Study Locations