Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib
- Registration Number
- NCT00802841
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.
- Detailed Description
The comparative efficacy between imatinib dose escalation (600 mg QD) and nilotinib (400 mg BID), in terms of CCyR after 6 months, for patients with CML in chronic phase with suboptimal response to imatinib standard dose will be determined.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nilotinib nilotinib Participants received 400 mg nilotinib twice daily (BID). Imatinib imatinib Participants received 600 mg imatinib once daily (QD).
- Primary Outcome Measures
Name Time Method Percentage of Participants With Complete Cytogenetic Response (CCyR) 6 months CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 24 months OS was defined as time from date of randomization to the date of the death.
Percentage of Participants With CCyr 12 and 24 months CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.
Percentage of Participants With Major Molecular Response (MMR) 12 and 24 months MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS).
Time to CCyR 24 months Time to CCyR was defined as time from date of randomization to date of first documented CCyR.
Progression-Free Survival (PFS) 24 months PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause.
Event-Free Survival (EFS) 24 months EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC.
Duration of CCyR 24 months Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇻🇪Maracaibo, Estado Zulia, Venezuela