Trial · NCT00103844

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

NCT00103844, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2010-01-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia. Trials, record NCT00103844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103844

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
NCT number: NCT00103844
Status: Completed
Phases: Phase 2
Enrollment: 150 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia
Interventions: Dasatinib, Imatinib
First posted: 2005-02-16
Last updated: 2010-08-10
Results first posted: 2010-01-07

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Major Cytogenetic Response (MCyR) at Week 12	Week 12	Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; \>0% to 35% Ph+ cells in metaphase in bone marrow).
Secondary	MCyR at Any Time Prior to Crossover	Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.	Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (\>0% to 35% Ph+ cells in metaphase in bone marrow).
Secondary	Duration of MCyR at 12 Months and 18 Months	12 months, 18 months	Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.
Secondary	Duration of MCyR at 24 Months	24 Months	Percentage of participants who achieved MCyR and did not progress at 24 months.
Secondary	Time to MCyR Prior to Crossover	Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.	Median time from first dosing date to date of MCyR
Secondary	Complete Hematologic Response (CHR) at Any Time Prior to Crossover	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.	Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Secondary	Duration of Complete Hematologic Response (CHR)	12 months, 24 months	Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Secondary	Time to CHR Prior to Crossover	Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.	Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.
Secondary	Major Molecular Response (MMR)	Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.	Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.
Secondary	CHR After Crossover	Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.	Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets \< 450,000/mm³; no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Major Cytogenetic Response (MCyR) at Week 12	Week 12	All randomized subjects	Participants	NUMBER
SECONDARY	MCyR at Any Time Prior to Crossover	Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.		Participants	NUMBER
SECONDARY	Duration of MCyR at 12 Months and 18 Months	12 months, 18 months		percentage of participants.	NUMBER
SECONDARY	Duration of MCyR at 24 Months	24 Months	In the imatinib group, the 24 months timepoint was beyond the maximum observed time.	Percentage of Participants	NUMBER
SECONDARY	Time to MCyR Prior to Crossover	Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.	Population consists of the number of responders in each treatment group	months	MEDIAN
SECONDARY	Complete Hematologic Response (CHR) at Any Time Prior to Crossover	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.		Participants	NUMBER
SECONDARY	Duration of Complete Hematologic Response (CHR)	12 months, 24 months	Number of participants achieving CHR in each treatment group	percentage of participants	NUMBER
SECONDARY	Time to CHR Prior to Crossover	Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.	Number of participants achieving CHR in each treatment group	weeks	MEDIAN
SECONDARY	Major Molecular Response (MMR)	Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.	Participants assessed for MMR only	participants	NUMBER
SECONDARY	CHR After Crossover	Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.	Participants evaluable for response after crossover	Participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12	Dasatinib		36	Participants
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12	Imatinib		14	Participants
MCyR at Any Time Prior to Crossover	Dasatinib	MCyR (CCyR + PCyR)	54	Participants
MCyR at Any Time Prior to Crossover	Imatinib	MCyR (CCyR + PCyR)	16	Participants
MCyR at Any Time Prior to Crossover	Dasatinib	CCyR (0% Ph+ cells)	44	Participants
MCyR at Any Time Prior to Crossover	Imatinib	CCyR (0% Ph+ cells)	9	Participants
MCyR at Any Time Prior to Crossover	Dasatinib	PCyR (>0% to 35% Ph+ cells)	10	Participants
MCyR at Any Time Prior to Crossover	Imatinib	PCyR (>0% to 35% Ph+ cells)	7	Participants
Duration of MCyR at 12 Months and 18 Months	Dasatinib	12 months	92	percentage of participants.
Duration of MCyR at 12 Months and 18 Months	Imatinib	12 months	74	percentage of participants.

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dasatinib First	101
Overall Study	STARTED	Imatinib First	49
Overall Study	Crossed Over	Dasatinib First	22
Overall Study	Crossed Over	Imatinib First	40
Overall Study	COMPLETED	Dasatinib First	101
Overall Study	COMPLETED	Imatinib First	49
Overall Study	NOT COMPLETED	Dasatinib First	0
Overall Study	NOT COMPLETED	Imatinib First	0

Source ClinicalTrials.gov

Adverse events246

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	EYE OEDEMA	Eye disorders	DASATINIB	1	101
other	EYE OEDEMA	Eye disorders	IMATINIB	3	49
other	EYELID OEDEMA	Eye disorders	DASATINIB	3	101
other	EYELID OEDEMA	Eye disorders	IMATINIB	4	49
other	CONJUNCTIVITIS	Eye disorders	DASATINIB	6	101
other	CONJUNCTIVITIS	Eye disorders	IMATINIB	2	49
other	CONJUNCTIVAL HAEMORRHAGE	Eye disorders	DASATINIB	6	101
other	CONJUNCTIVAL HAEMORRHAGE	Eye disorders	IMATINIB	0	49
other	WEIGHT DECREASED	Investigations	DASATINIB	27	101
other	WEIGHT DECREASED	Investigations	IMATINIB	4	49

1 to 10 of 246Source ClinicalTrials.gov

See all 246 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DASATINIB
Total, all-cause mortality	IMATINIB
Total, other adverse events	DASATINIB	99	101
Total, other adverse events	IMATINIB	43	49
Total, serious adverse events	DASATINIB	43	101
Total, serious adverse events	IMATINIB	4	49

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19536906	BACKGROUND	PubMed
19779040	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dasatinib vs Imatinib: Major Molecular Response (MMR)	Trial comparisons
Dasatinib vs Imatinib: Number of Participants With Major Cytogenetic Response (MCyR) at Week 12	Trial comparisons
Dasatinib vs Imatinib: Complete Hematologic Response (CHR) at Any Time Prior to Crossover	Trial comparisons
Dasatinib vs Imatinib: CHR After Crossover	Trial comparisons
DASATINIB vs IMATINIB: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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