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Nilotinib Plus Pegylated Interferon Alpha 2a for de Novo CP CML
NCT01294618Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2011
- Primary completion
- Mar 2011
- Countries
- 1
- Sponsor
- Hospices Civils de Lyon
- Modality
- Small Molecules
- Conditions
- chronic myelogenous leukemia (CML)
01
Overview
Phase 2, open-label, single-arm trial of nilotinib and peginterferon alfa-2a in chronic myelogenous leukemia (CML), sponsored by Hospices Civils de Lyon. Primary endpoint: Complete Molecular Remission at 12 months. Started Mar 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
nilotinib + pegylated interferon alpha 2a (PEG-IFN)
Nilotinib 300 mg twice a day + Pegylated interferon 2a 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.
03
Who it enrols
Newly diagnosed (<= 3 months) Chronic Phase CML patients with M-bcr transcript, no prior TKI or interferon treatment, adequate organ function, and no significant cardiac or severe uncontrolled diseases.
04
Endpoints
Primary
Complete Molecular Remission
Secondary
Kinetics of Complete Molecular Response
Stability of Complete Molecular Response
Kinetics of Major Molecular Response
Stability of Major Molecular Response
Complete Cytogenetic Remission
Safety and Tolerability
Dose reductions or interruptions
Progression-Free Survival
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