Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00038610|
Recruitment Status : Completed
First Posted : June 4, 2002
Results First Posted : September 18, 2015
Last Update Posted : September 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Imatinib Mesylate Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Methotrexate Drug: Cytarabine Drug: Mesna Drug: G-CSF||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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.
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.
Other Name: Decadron
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.
Other Name: Mesnex
10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
- Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate [ Time Frame: Baseline to 6 months ]
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 ]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 ]Overall survival (OS) was calculated from the date of initiation of therapy until death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038610
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naval Daver, MD||M.D. Anderson Cancer Center|