Trial Outcomes & Findings for A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy (NCT NCT00362466)

Results Overview

Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

Month 6

Results posted on

2009-11-20

Participant Flow

A total of 156 subjects were to be enrolled; however, the attempts were unsuccessful and the study was closed after 3 subjects were enrolled. A fourth subject underwent screening, but was not randomized since the subject did not meet the inclusion criteria.

Participant milestones

Participant milestones
Measure	Dasatinib 100 mg once daily (QD)	Imatinib 600 mg QD
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib n=2 Participants 100 mg QD	Imatinib n=1 Participants 600 mg QD	Total n=3 Participants Total of all reporting groups
Age Continuous 30- to 39-years-old	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous 40- to 49-years-old	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous 50- to 59-years-old	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: This analysis was not done. This study was terminated due to insufficient enrollment.

Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 3, Month 6, Month 12, Month 24 and Month 36

Population: This analysis was not done. This study was terminated due to insufficient enrollment.

MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 3, Month 12, Month 24 and Month 36

Population: This analysis was not done. This study was terminated due to insufficient enrollment.

CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: throughout the study

Population: This analysis was not done. This study was terminated due to insufficient enrollment.

Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 36 months

Population: This analysis was not done. This study was terminated due to insufficient enrollment.

PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.

Population: All treated participants

An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Outcome measures

Outcome measures
Measure	Dasatinib n=2 Participants 100 mg QD	Imatinib n=1 Participants 600 mg QD
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs AEs	3 events	1 events
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs SAEs	0 events	0 events
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs AEs leading to Discontinuation	0 events	0 events
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs Deaths	0 events	0 events

SECONDARY outcome

Timeframe: Throughout the study

Population: This analysis was not done. This study was terminated due to insufficient enrollment.

Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: throughout study

Population: This analysis was not done. This study was terminated due to insufficient enrollment.

MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.

Outcome measures

Outcome data not reported

Adverse Events

Dasatinib

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Imatinib

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dasatinib n=2 participants at risk 100 mg once daily (QD)	Imatinib n=1 participants at risk 600 mg QD
Skin and subcutaneous tissue disorders Rash	50.0% 1/2	0.00% 0/1
Blood and lymphatic system disorders Neutropenia	50.0% 1/2	0.00% 0/1
Nervous system disorders Headache	50.0% 1/2	0.00% 0/1
Investigations Hypokalemia	0.00% 0/2	100.0% 1/1

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER