Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00103844
First received: February 15, 2005
Last updated: August 3, 2010
Last verified: June 2010
History of Changes
Results First Received: December 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Myeloid Leukemia
Philadelphia-Positive Myeloid Leukemia
Interventions: Drug: Dasatinib
Drug: Imatinib

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
166 subjects enrolled; 16 failed screening and were not treated (2 subjects were double-randomizations, 13 subjects failed inclusion criteria, 1 subject withdrew consent during screening.)

Reporting Groups
  Description
Dasatinib First Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period).
Imatinib First Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).

Participant Flow:   Overall Study
    Dasatinib First     Imatinib First  
STARTED     101     49  
Crossed Over     22 [1]   40 [2]
COMPLETED     101 [3]   49 [3]
NOT COMPLETED     0     0  
[1] 22 participants from the dasatinib arm crossed over to imatinib
[2] 40 participants from the imatinib arm crossed over the dasatinib
[3] Completed=no longer on treatment.Treatment continued until disease progression/intolerable toxicity.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dasatinib Dasatinib 70 mg twice a day (BID)
Imatinib Imatinib 400 mg BID
Total Total of all reporting groups

Baseline Measures
    Dasatinib     Imatinib     Total  
Number of Participants  
[units: participants]
 		  101     49     150  
Age, Customized  
[units: participants]
 		     
Between 21 and 45 years     36     15     51  
Between 46 and 65 years     48     28     76  
Between 66 and 75 years     13     5     18  
>75 years     4     1     5  
Age  
[units: years]
Mean ± Standard Deviation 		  51  ± 13.6     50  ± 13.6     51  ± 13.6  
Gender  
[units: participants]
 		     
Female     48     27     75  
Male     53     22     75  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Asian     6     3     9  
Black or African American     2     1     3  
White     87     43     130  
Other     6     2     8  
Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) [1]
[units: Participants]
 		     
Score=0 (fully active)     71     34     105  
Score=1 (ambulatory, light/sedentary work)     27     12     39  
Score=2 (ambulatory, all selfcare, unable to work)     0     0     0  
Score=3 (limited selfcare, some bed confinement)     0     0     0  
Score=4 (completely disabled)     0     0     0  
Score=5 (dead)     0     0     0  
Not Reported     3     3     6  
[1] ECOG PS: a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale: 0-5, with 0=fully active, able to carry on all pre-disease performance without restriction and 5=death.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Major Cytogenetic Response (MCyR) at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 1

2.  Secondary:   MCyR at Any Time Prior to Crossover   [ Time Frame: Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements. ]
  Show Outcome Measure 2

3.  Secondary:   Duration of MCyR at 12 Months and 18 Months   [ Time Frame: 12 months, 18 months ]
  Show Outcome Measure 3

4.  Secondary:   Duration of MCyR at 24 Months   [ Time Frame: 24 Months ]
  Show Outcome Measure 4

5.  Secondary:   Time to MCyR Prior to Crossover   [ Time Frame: Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements. ]
  Show Outcome Measure 5

6.  Secondary:   Complete Hematologic Response (CHR) at Any Time Prior to Crossover   [ Time Frame: Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements. ]
  Show Outcome Measure 6

7.  Secondary:   Duration of Complete Hematologic Response (CHR)   [ Time Frame: 12 months, 24 months ]
  Show Outcome Measure 7

8.  Secondary:   Time to CHR Prior to Crossover   [ Time Frame: Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements. ]
  Show Outcome Measure 8

9.  Secondary:   Major Molecular Response (MMR)   [ Time Frame: Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements. ]
  Show Outcome Measure 9

10.  Secondary:   CHR After Crossover   [ Time Frame: Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements. ]
  Show Outcome Measure 10

11.  Secondary:   Cytogenetic Response After Crossover   [ Time Frame: every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements ]
  Show Outcome Measure 11

12.  Secondary:   Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover   [ Time Frame: Continuously from baseline through 2 years ]
  Show Outcome Measure 12

13.  Secondary:   Health-Related Quality of Life Prior to Crossover   [ Time Frame: Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date. ]
  Show Outcome Measure 13

14.  Secondary:   Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib   [ Time Frame: Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose. ]
  Show Outcome Measure 14


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications:


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00103844     History of Changes
Other Study ID Numbers: CA180-017
Study First Received: February 15, 2005
Results First Received: December 2, 2009
Last Updated: August 3, 2010
Health Authority: United States: Food and Drug Administration