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
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Phase Chronic Myeloid Leukemia||Drug: Imatinib Drug: Dasatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||262 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 Major Molecular Response (MMR) After 12 Months of CML Treatment [ Time Frame: At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib. ]
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals.
P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (<=4 weeks vs >4 weeks). Month 12 is calculated fro
- Median 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|