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Nilotinib plus chemotherapy for newly diagnosed Ph+ ALL
NCT00844298Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2009
- Primary completion
- Jun 2012
- Countries
- 1
- Sponsor
- Asan Medical Center
- Modality
- Small Molecules
- Drugs
- nilotinib
- Conditions
- acute lymphoblastic leukemia (ALL)mixed phenotype acute leukemia (MPAL)
01
Overview
Phase 2, open-label, single-arm trial of nilotinib in acute lymphoblastic leukemia (ALL) and mixed phenotype acute leukemia (MPAL), sponsored by Asan Medical Center. Primary endpoint: Hematologic and Molecular Complete Remission Rate at 1 month. Started Jan 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Nilotinib+mVPD
Nilotinib combined with multi-agent chemotherapy followed by maintenance
03
Who it enrols
Patients aged 15 years or older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia or acute mixed lineage leukemia, ECOG 0-2, and adequate organ function.
04
Endpoints
Primary
Hematologic and Molecular Complete Remission Rate
Secondary
Disease-Free Survival
Overall Survival
Toxicity of Regimen
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