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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Imatinib Mesylate; Lenograstim; Liposomal doxorubicin; Mesna; Methotrexate; Vincristine

Criteria

Inclusion Criteria:

1. Diagnosis of previously untreated Ph-positive ALL or previously treated in CR after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.

2. Age > or = 15 years. Those < 15 years of age will be treated under compassionate IND.

3. Zubrod performance status < or = 2 (ECOG Scale, Appendix A).

4. Adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).

5. Adequate cardiac function as assessed clinically by physical examination.

6. Signed informed consent.

Exclusion Criteria:

1. Active serious infection not controlled by oral or intravenous antibiotics.

2. Treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening.

3. Active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.

4. History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.

5. Prior history of treatment with imatinib mesylate.

6. Pregnancy or lactating in women of childbearing potential.