drugset / Trial / NCT00038610
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2001-03
- Primary completion
- 2014-07
- Completion
- 2014-07
Publications
- Ribera JM, Prawitz T, Freitag A, Sharma A, Dobi B, Rizzo F, Sabatelli L, Patos P. Ponatinib vs. Imatinib as Frontline Treatment for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Matching Adjusted Indirect Comparison. Adv Ther. 2023 Jul;40(7):3087-3103. doi: 10.1007/s12325-023-02497-y. Epub 2023 May 19.
- Daver N, Thomas D, Ravandi F, Cortes J, Garris R, Jabbour E, Garcia-Manero G, Borthakur G, Kadia T, Rytting M, Konopleva M, Kantarjian H, O'Brien S. Final report of a phase II study of imatinib mesylate with hyper-CVAD for the front-line treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Haematologica. 2015 May;100(5):653-61. doi: 10.3324/haematol.2014.118588. Epub 2015 Feb 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 100 mg | Intrathecal |
| Subject | Cytarabine | Small molecule | 3 g | Intrathecal |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Imatinib | Small molecule | 600 mg | Oral |
| Subject | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Subject | Methotrexate | Small molecule | 200 mg/m2 | Intrathecal |
| Subject | Methotrexate | Small molecule | 800 mg/m2 | Intrathecal |
| Subject | Vincristine | Small molecule | 2 mg | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 600 mg/m2 | Intravenous |
| Background | G-CSF | Unknown | 10 ug/kg | Subcutaneous |