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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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

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.
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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
Overall Participants Analyzed  [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.

1.  Primary:

Number of Participants With Major Cytogenetic Response (MCyR) at Week 12   [ Time Frame: Week 12 ]

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. ]

3.  Secondary:

Duration of MCyR at 12 Months and 18 Months   [ Time Frame: 12 months, 18 months ]

4.  Secondary:

Duration of MCyR at 24 Months   [ Time Frame: 24 Months ]

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. ]

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. ]

7.  Secondary:

Duration of Complete Hematologic Response (CHR)   [ Time Frame: 12 months, 24 months ]

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. ]

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. ]

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. ]

11.  Secondary:

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

12.  Secondary:

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

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. ]

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. ]

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
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