NCT01605981

Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.

A Phase II, Non Randomized, Open Label, Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, non randomized, prospective, multicenter, phase II clinical trial evaluating nilotinib 400 mg BID for the treatment of newly diagnosed CML-AP patients. Patients enrolled into the study will receive 400mg of nilotinib, orally, twice daily (800mg/day)

Detailed description

Patients will be evaluated for safety throughout the study and for response every month for the first 3 months, then every 3 months thereafter up to month 24. BCR-ABL transcripts measurement by QRT-PCR and mutation analyses will be done on peripheral blood samples and cytogenetic analyses on bone marrow aspirates. Laboratory tests (hematology, blood chemistry), ECG and physical examination will be done on every visit. Drug pharmacokinetics will be assessed in this study. For the screening Baseline periods, see chart attached

Conditions

• Chronic Myeloid Leukemia (CML)

Interventions

Type	Name	Description
DRUG	AMN107

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2012-05-25
• Last updated: 2017-04-20

Locations

18 sites across 1 country: Brazil