Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Drug: Imatinib Mesylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia|
- Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.
Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.
Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.
Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease.
- Disease-Free Survival Rate at 2-year and 5-year. [ Time Frame: Baseline to 2-year and 5-year ] [ Designated as safety issue: No ]Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.
- Overall Survival Rate at 2-year and 5-year. [ Time Frame: Baseline to 2-year and 5-year ] [ Designated as safety issue: No ]Overall survival (OS) was calculated from the date of initiation of therapy until death.
|Study Start Date:||March 2001|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Hyper-CVAD + Imatinib
Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
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.
Other Names: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.
Other Names:Drug: Doxorubicin
50 mg/m^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7.
Other Names: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.
Other Name: DecadronDrug: 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.
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.
Other Names:Drug: Mesna
600 mg/m^2 by vein daily for 24 hours for courses 1, 3, 5, 7.
Other Name: MesnexDrug: G-CSF
10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038610
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naval Daver, MD||M.D. Anderson Cancer Center|