Leukemia Clinical Trial
Official title:
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
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.
Induction therapy:
- Imatinib 200-400 mg p.o. daily x 10 days, Days 1-10 (see dose escalation scheme in
Section 5.4 below).
- Mitoxantrone 10 mg/m2 daily x 5 days, Days 4-8.
- Etoposide 100 mg/m2 daily x 5 days, Days 4-8.
- Cytarabine 1.5 grams/m2 q12h x 4 doses, Days 9-10 (for patients aged 60 years and over,
1.0 gram/m2).
Only one induction course will be permitted. Only patients achieving CR will proceed to
consolidation and maintenance.
Consolidation therapy, maximum 2 cycles (for patients achieving CR):
- Imatinib 200-400 mg p.o. daily x 8 days, Days 1-8 (see dose escalation scheme in
Section 5.4 below).
- Mitoxantrone 12 mg/m2 daily x 2 days, Days 4-5.
- Cytarabine 3 grams/m2 q12h x 6 doses, Days 4,6,8. For patients aged 60 years and over,
the dose will be reduced to 1.5 grams/m2.
Maintenance therapy (for patients still in CR at end of consolidation):
Imatinib 600 mg p.o. daily, until relapse or toxicity (see dose modification criteria in
Section 5.6.6 below). Patients must receive at least one consolidation cycle before being
permitted to proceed to maintenance therapy (see Section 5.6 for details). Maintenance
therapy with imatinib will be provided for a maximum period of 1 year.
Dose escalation scheme:
Imatinib will be used during induction and consolidation at one of the following dose
levels:
Level -1 100 mg daily Level 1 200 mg daily Level 2 300 mg daily Level 3 400 mg daily
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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