Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib (LASOR)
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|ClinicalTrials.gov Identifier: NCT00802841|
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : November 16, 2015
Last Update Posted : November 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelogenous Leukemia||Drug: nilotinib Drug: imatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||191 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase Lll Study of Imatinib Dose Optimization Compared With Nilotinib in Patients With Chronic Myelogenous Leukemia and Suboptimal Response to Standard-dose Imatinib|
|Study Start Date :||May 2009|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
Participants received 400 mg nilotinib twice daily (BID).
Supplied as 200 mg tablets
Other Name: Tasigna
Active Comparator: Imatinib
Participants received 600 mg imatinib once daily (QD).
Supplied as 100 mg and 400 mg tablets
Other Name: Gleevec/Glivec
- Percentage of Participants With Complete Cytogenetic Response (CCyR) [ Time Frame: 6 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) [ Time Frame: 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).
- Percentage of Participants With CCyr [ Time Frame: 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.
- Time to CCyR [ Time Frame: 24 months ]Time to CCyR was defined as time from date of randomization to date of first documented CCyR.
- Duration of CCyR [ Time Frame: 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.
- Progression-Free Survival (PFS) [ Time Frame: 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) [ Time Frame: 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.
- Overall Survival (OS) [ Time Frame: 24 months ]OS was defined as time from date of randomization to the date of the death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802841
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|