Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib (DASCERN)
|ClinicalTrials.gov Identifier: NCT01593254|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Phase Chronic Myeloid Leukemia||Drug: Imatinib Drug: Dasatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib|
|Actual Study Start Date :||October 29, 2012|
|Actual Primary Completion Date :||November 8, 2017|
|Estimated Study Completion Date :||February 17, 2022|
Active Comparator: Arm 1: Imatinib (≥400 mg)
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months
Active Comparator: Arm 2: Dasatinib (100 mg)
Dasatinib 100 mg tablet by mouth QD up to 60 months
Other Name: Sprycel
- Percentage of patients achieving optimal response after 12 months of CML treatment [ Time Frame: 12 months after the first day treatment with first-line imatinib ]
- Time to Major Molecular Response (MMR) [ Time Frame: Up to 10 years ]Time to MMR is how fast patients achieve optimal response. It is the time between randomization date and first date that MMR criteria are satisfied.
- Time to Molecular Response (MR)^4.5 [ Time Frame: Up to 10 years ]Time to MR^4.5 is how fast patients achieve a deeper response. It is the time between randomization date and first date that MR^4.5 criteria are satisfied.
- Progression Free Survival (PFS) [ Time Frame: Up to 10 years ]PFS is how long patients are likely to live without progression of their disease. It is the time from randomization date to progression date or death date, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 10 years ]OS is how long patients are likely to remain alive. It is the time from randomization date to death date.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593254
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|