What role does genetics play in cancer susceptibility?
Brief Summary:
This is a phase III trial comparing, for newly diagnosed chronic phase CML patients, nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa 2 a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is the rate patients obtaining MR4.5 will be measured at this time point.
| Condition or disease | Intervention/treatment | Phase |
| Chronic Myeloid Leukemia | Drug: Nilotinib (Tasigna ®), capsules of 150 mgDrug: Nilotinib (Tasigna ®) and Pegylated interferon alfa 2a (Pegasys®) | Phase 3 |
Primary Outcome Measures :
- Molecular response (MR) 4.5 at 12 months of nilotinib 300 mg twice a day versus a combination of low-dose Peg-Interferon (Peg-IFN) to nilotinib 300 mg twice a day in newly diagnosed CP-CML Chronic Phase Chronic Myelogenous Leukemia patients. [ Time Frame: 12 months ]Centralised assessment of the BCR-ABL transcripts at 12 months since nilotinib initiation
Secondary Outcome Measures :
Molecular Response 4.5 at 1, 2, 3, 6, 9, 12 months of nilotinib, and duration of MR4.5 during the second year of treatment (18, 24 and 36 months). [ Time Frame: 36 months ]Centralised assessment of the BCR-ABL transcripts every month for 3 months and every three months until 12 months and thereafter every 6 months until 36 months assessment.
Major Molecular Response at 1, 2, 3, 6, 9, 12 months of nilotinib, and duration of MMR during the second year of treatment (18, 24 and 36 months). [ Time Frame: 36 months ]Centralised assessment of the BCR-ABL transcripts every month for 3 months and every three months until 12 months and thereafter every 6 months until 36 months assessment.
Rate of patients with BCR-ABL/ABL (IS) ≥10% at 3 months. [ Time Frame: 3 months after nilotinib initiation ]Centralised assessment of the BCR-ABL transcripts at 3 months.