Spots Global Cancer Trial Database for Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients

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Trial Identification

Brief Title: Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients

Official Title: Randomized Multicenter Phase III Study Comparing the Rate of Molecular Response 4.5 at 12 Months in Newly Diagnosed Philadelphia Positive Chronic Phase Chronic Myelogenous Leukemia Patients Receiving Either Frontline Nilotinib 600 mg Daily or Nilotinib 600 mg Daily Combined to Pegylated Interferon-alfa 2a (Peg-IFN)

Study ID: NCT02201459

Conditions

Chronic Myeloid Leukemia

Interventions

Nilotinib (Tasigna ®), capsules of 150 mg

Nilotinib (Tasigna ®) and Pegylated interferon alfa 2a (Pegasys®)

Study Description

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.

Detailed Description: