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

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

October 31, 2022

Study Completion Date

October 31, 2022

Conditions
Chronic Myeloid Leukemia
Interventions
DRUG

Nilotinib (Tasigna ®), capsules of 150 mg

Nilotinib 2 capsules of 150 mg orally twice daily at 12 hours difference, fasting (minimum 1 hour before or 2 hours after a meal) for at least 36 months

DRUG

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

"* Nilotinib 2 capsules of 150 mg orally twice daily at 12 hours difference, fasting (minimum 1 hour before or 2 hours after a meal) for at least 36 months and~* Pegylated interferon alfa 2a subcutaneously once a week (auto-injection syringes of 135 and 90 micrograms) at 30 micrograms/week the first month alone (= priming procedure), then at 30 micrograms/2weeks the first month of combination to nilotinib and then at 45 micrograms/week thereafter until month 24 after nilotinib initiation."

Trial Locations (1)

04 78 86 22 50

Franck NICOLINI, Lyon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Hospices Civils de Lyon

OTHER