Clinical trial · Interventional
A Study of Imatinib With Reinduction Chemotherapy Using Mitoxantrone, Etoposide and Cytarabine in Patients With Relapsed/Refractory C-kit Positive (AML) Acute Myeloid Leukemia
A Phase I-II Study Evaluating the Safety and Efficacy of Imatinib Mesylate (Gleevec) Combined With Reinduction Chemotherapy Using Mitoxantrone, Etoposide and Cytarabine in Patients With Relapsed/Refractory C-kit Positive Acute Myeloid 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)
This is a Phase I-II study evaluating the toxicity and efficacy of imatinib combined with mitoxantrone, etoposide and high-dose cytarabine reinduction therapy in relapsed and refractory AML. Patients will be treated initially at a 200 mg dose of imatinib; if tolerated, the imatinib dose will be escalated in subsequent cohorts to 300 mg and 400 mg. Once the recommended dose is determined, the remaining patients will be treated at that dose, to evaluate the antileukemic activity of the regimen. Patients achieving complete remission will receive consolidation therapy with imatinib combined with high-dose cytarabine and mitoxantrone, followed by maintenance imatinib.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib (Gleevec) | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- one
- interventionNames
- Drug: Imatinib (Gleevec)
Primary outcomes (3)
- measure
- Toxicity (hematologic and non-hematologic) of the combination of Imatinib and Chemotherapy consisting of Mitoxantrone, Etoposide and Ara-c
- timeFrame
- 2 years
- description
- Hematologic toxicity * Number of days to ANC \> 0.5 and 1.0. * Number of days until platelets \> 20 and \> 50, independent of platelet transfusions. * Number of days until RBC transfusion independent. Non-hematologic toxicity, as per NCI common toxicity criteria Hematologic dose-limiting toxicity (DLT) defined as \> 40 days to ANC \> 0.5 or platelets \> 20 independent of transfusions.
- measure
- Response rate - CR, MLFS and PR as per section 7.1
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * AML, all subtypes except APL. * Prior induction therapy consisting of cytarabine 100-200 mg/m2 plus an anthracycline. * One of the following: * persistent leukemia after induction therapy. * relapse within two years of achieving complete remission with induction therapy. Any consolidation therapy is acceptable, including stem cell transplantation. * At least 10% bone marrow blasts, or biopsy confirmed extramedullary disease. * Positivity for c-kit (CD117) in at least 30% of blasts as measured by flow cytometry. * Aged 18-65. * ECOG performance status \< 3 (see Appendix I). * No chemotherapy within the previous four weeks, other than hydroxyurea to control counts. If hydroxyurea is used, it must be stopped at least 24 hours prior to starting imatinib. * Able to given informed consent. Exclusion Criteria: * Active uncontrolled infection. * Active CNS leukemia. * Serum creatinine \> 200 umol/L. * Serum bilirubin \> 1.5 x ULN, AST or ALT \> 2x ULN. * Left ventricular ejection fraction \< 50%.
References
Publications (0)
Data not yet available