Clinical trial · Interventional
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Vincristine |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyper-CVAD + Imatinib
- description
- 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.
- interventionNames
- Drug: Imatinib Mesylate
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Dexamethasone
- Drug: Methotrexate
- Drug: Cytarabine
- Drug: Mesna
- Drug: G-CSF
Primary outcomes (2)
- measure
- Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Age \> or = 15 years. Those \< 15 years of age will be treated under compassionate IND. 3. Zubrod performance status \< or = 2 (ECOG Scale, Appendix A). 4. 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). 5. Adequate cardiac function as assessed clinically by physical examination. 6. Signed informed consent. Exclusion Criteria: 1. Active serious infection not controlled by oral or intravenous antibiotics. 2. 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. 3. 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. 4. History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. 5. Prior history of treatment with imatinib mesylate. 6. Pregnancy or lactating in women of childbearing potential.
References
Publications (2)
- DERIVEDRibera 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. PMID 37208556
- DERIVEDDaver 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. PMID 25682595