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

Completed · Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT00038610

Run by

M.D. Anderson Cancer Center

People needed

54

Starts

2001-03-01

Expected to finish

2014-07-01

Last updated by the study team

2015-09-18

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Age > or = 15 years. Those < 15 years of age will be treated under compassionate IND.
• Zubrod performance status < or = 2 (ECOG Scale, Appendix A).
• 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).
• Adequate cardiac function as assessed clinically by physical examination.
• Signed informed consent.

You may not qualify if…

• Active serious infection not controlled by oral or intravenous antibiotics.
• 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.
• 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.
• History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
• Prior history of treatment with imatinib mesylate.
• Pregnancy or lactating in women of childbearing potential.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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