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 : November 1, 2019
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Sponsor:
Bristol-Myers Squibb
Collaborators:
ICON Clinical Research
PPD
Molecular MD
MultiPharma
Q2 Solutions
Donald E. Morisky
MD Anderson Symptom Inventory (MDASI-CML)
OBiS, Inc
Steering Committee
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Tracking Information | ||||
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First Submitted Date ICMJE | May 4, 2012 | |||
First Posted Date ICMJE | May 8, 2012 | |||
Results First Submitted Date ICMJE | November 8, 2018 | |||
Results First Posted Date ICMJE | April 11, 2019 | |||
Last Update Posted Date | November 1, 2019 | |||
Actual Study Start Date ICMJE | October 29, 2012 | |||
Actual Primary Completion Date | November 8, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
Proportion of subjects who achieve Major Molecular Response (MMR) rate [ Time Frame: At 12 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Phase Chronic Myeloid Leukemia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
262 | |||
Original Estimated Enrollment ICMJE |
180 | |||
Estimated Study Completion Date ICMJE | February 17, 2022 | |||
Actual Primary Completion Date | November 8, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Austria, Belgium, Brazil, Canada, China, Czechia, France, Hungary, Italy, Korea, Republic of, Poland, Spain, Thailand, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01593254 | |||
Other Study ID Numbers ICMJE | CA180-399 2011-006181-41 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Bristol-Myers Squibb | |||
Study Sponsor ICMJE | Bristol-Myers Squibb | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | |||
Verification Date | October 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |