At a glance
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Tasigna® (Nilotinib) Plus Multi-Agent Chemotherapy for Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
In Brief
A Phase 2 clinical trial evaluating Nilotinib+mVPD for Leukemia. Completed, enrolled 91 participants across 16 sites.
Detailed Summary
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving nilotinib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving nilotinib together with combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.
Study Details
Timeline
Interventions
1. Induction: * Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3) * Vincristine 2 mg iv push (d1, 8, 15, 22) * Prednisolone 60 mg/m2/day po (d1-28) * Nilotinib 400mg bid/d (d8-) 2. Consolidation A (cycle1) * Daunorubicin 45 mg/m2/day by continuous iv (d1, 2) * Vincristine 2 mg iv (d1, 8) * Prednisolone 60 mg/m2/day po (d1-14) * Nilotinib 400mg bid/d 3. Consolidation B (cycles 2\&4) * Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4) * Etoposide 150 mg/m2/day iv over 3 hours (d1-4) * Nilotinib 400mg bid/d 4. Consolidation C (cycles 3\&5) * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16) * Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses, * Nilotinib 400mg bid/d 5. Maintenance ◦Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT) 6. Consider alloHCT