Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib (DASCERN)
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|ClinicalTrials.gov Identifier: NCT01593254|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : June 20, 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.
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): NCT01593254
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|