At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of previously untreated Ph-positive ALL, or previously treated in complete remission (CR) after 1-2 courses of therapy, or failure after one course of induction chemotherapy without imatinib mesylate
- ✓Age 15 years or older
- ✓ECOG performance status 0-2
- ✓Adequate liver function (bilirubin ≤3.0 mg/dL unless from tumor) and renal function (creatinine ≤3.0 mg/dL unless from tumor)
- ✕Active serious infection not controlled by oral or intravenous antibiotics
- ✕Treatment with investigational antileukemic agent or chemotherapy in the last 7 days before entry (unless full recovery or life-threatening progressive disease)
- ✕Active secondary malignancy other than skin cancer, in investigator's opinion shortening survival to <1 year
- ✕History of Grade III/IV cardiac problems per New York Heart Association Criteria
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating Imatinib Mesylate, Cyclophosphamide, and 7 other interventions for Leukemia. Completed, enrolled 54 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
50 mg/m\^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7.
2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7.
40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7.
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.
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.
600 mg/m\^2 by vein daily for 24 hours for courses 1, 3, 5, 7.
10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.