Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Phase 3

Terminated

• Conditions: Myelogenous Leukemia
• Interventions: Drug: Nilotinib (AMN107); Drug: Imatinib

• Registration Number: NCT00519090
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

Detailed Description

This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (PCyR), but no CCyR.

Study Timeline

• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-21
• Study Start: 2007-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2010-11-11
• Results First Submitted QC: 2011-04-07
• Results First Posted: 2011-05-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nilotinib (AMN107)	Nilotinib (AMN107)	-
Imatinib	Imatinib	-

Primary Outcome Measures

Name	Time	Method
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib	12 months	Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.

Secondary Outcome Measures

Name	Time	Method
Durable Complete Cytogenetic Response Rate	24 months	Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.

Trial Locations

Locations (30)

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Southern California Permanente Medical Group; 🇺🇸 San Diego, California, United States

Kaiser Permanente Medical Group/Hayward Medical Center; 🇺🇸 Hayward, California, United States

Kaiser Permanente Medical Group/Oakland Medical Center; 🇺🇸 Oakland, California, United States

Kaiser Permanente Medical Group/South San Francisco Medical Center; 🇺🇸 S. San Francisco, California, United States

Kaiser Permanente Medical Group/Sacramento Medical Center; 🇺🇸 Sacramento, California, United States

Kaiser Permanente Medical Group; 🇺🇸 San Jose, California, United States

Kaiser Permanente Medical Group/Santa Clara Medical Office; 🇺🇸 Santa Clara, California, United States

Kaiser Permanente Medical Group/Vallejo Medical Center; 🇺🇸 Vallejo, California, United States

Kaiser Permanente Medical Group/Walnut Creek Medical Center; 🇺🇸 Walnut Creek, California, United States

Scroll for more (20 remaining)