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 |
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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
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Chronic Phase Chronic Myeloid Leukemia |
| Interventions |
Drug: Imatinib Drug: Dasatinib |
| Enrollment | 262 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 262 were enrolled. 260 were randomized. 2 were not randomized due to failure to meet inclusion/exclusion criteria |
| Arm/Group Title | Arm 1: Imatinib (≥400 mg) | Arm 2: Dasatinib (100 mg) |
|---|---|---|
 Arm/Group Description |
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. Participants randomized to Imatinib that crossover to Dasatinib (n= 42); Participants randomized to Imatinib, no crossover (n = 44) | Dasatinib 100 mg tablet by mouth QD up to 60 months |
| Period Title: Treatment Period | ||
| Started [1] | 86 | 174 |
| Crossed Over to Dasatinib | 42 | 0 |
| Completed [2] | 72 | 143 |
| Not Completed | 14 | 31 |
| Reason Not Completed | ||
| Treatment Failure | 1 | 2 |
| Pregnancy | 0 | 1 |
| Poor/Non-Compliance | 2 | 1 |
| Maximum clinical benefit | 1 | 0 |
| Subject withdrew consent | 0 | 5 |
| Subject Request to Discontinue | 1 | 1 |
| AE unrelated to Study Drug | 0 | 1 |
| Death | 2 | 1 |
| Study Drug Toxicity | 3 | 9 |
| Disease Progression | 1 | 6 |
| Did Not Achieve RCC | 0 | 1 |
| Patient Refused to Return | 0 | 1 |
| No Response | 1 | 0 |
| T315I MUTATION | 0 | 1 |
| Investigator Decision | 2 | 1 |
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[1]
Started = Started Treatment Period
[2]
Completed = Continuing in Treatment Period
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| Period Title: Follow-Up Period | ||
| Started [1] | 14 | 28 |
| Completed [2] | 11 | 17 |
| Not Completed | 3 | 11 |
| Reason Not Completed | ||
| Withdrawal by Subject | 0 | 2 |
| Non-Compliance | 1 | 0 |
| Death | 2 | 2 |
| Subject request to Discontinue | 0 | 1 |
| Pregnancy | 0 | 1 |
| Study Drug Toxicity | 0 | 1 |
| Patient refused to return | 0 | 1 |
| Fundus Hemorrhage | 0 | 1 |
| Disease Progression | 0 | 1 |
| Study Drug Side Effects | 0 | 1 |
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[1]
Started Follow-Up Period
[2]
Continuing in the Follow-Up Period
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Baseline Characteristics
| Arm/Group Title | Arm 1: Imatinib (≥400 mg) | Arm 2: Dasatinib (100 mg) | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. Participants randomized to Imatinib that crossover to Dasatinib (n= 42); Participants randomized to Imatinib, no crossover (n = 44) | Dasatinib 100 mg tablet by mouth QD up to 60 months | Total of all reporting groups | |
| Overall Number of Baseline Participants | 86 | 174 | 260 | |
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Baseline Analysis Population Description |
All Randomized participants
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Age, Continuous
[1] Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 86 participants | 174 participants | 260 participants | |
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39.5
(18 to 73)
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35.0
(18 to 82)
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37.0
(18 to 82)
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[1]
Measure Analysis Population Description: All Randomized Participants
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 86 participants | 174 participants | 260 participants | |
| Female |
16 18.6%
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41 23.6%
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57 21.9%
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| Male |
70 81.4%
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133 76.4%
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203 78.1%
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[1]
Measure Analysis Population Description: All Randomized Participants
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Ethnicity (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 86 participants | 174 participants | 260 participants | |
| Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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| Not Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
86 100.0%
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174 100.0%
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260 100.0%
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[1]
Measure Analysis Population Description: All Randomized Participants
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 86 participants | 174 participants | 260 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
63 73.3%
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127 73.0%
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190 73.1%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
3 3.5%
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4 2.3%
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7 2.7%
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| White |
15 17.4%
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36 20.7%
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51 19.6%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
5 5.8%
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7 4.0%
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12 4.6%
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[1]
Measure Analysis Population Description: All Randomized Participants
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title: | Bristol-Myers Squibb Study Director |
| Organization: | Bristol-Myers Squibb |
| Phone: | Please Email: |
| EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01593254 |
| Other Study ID Numbers: |
CA180-399 2011-006181-41 ( EudraCT Number ) |
| First Submitted: | May 4, 2012 |
| First Posted: | May 8, 2012 |
| Results First Submitted: | November 8, 2018 |
| Results First Posted: | April 11, 2019 |
| Last Update Posted: | November 1, 2019 |