Phase 3 N=670 Randomized Treatment

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

Myeloid Leukemia, Chronic, Chronic-Phase

Bottom Line

View on ClinicalTrials.gov: NCT00123474 ↗

Enrolled (actual)

670

Serious AEs

50.4%

Results posted

Aug 2015

Primary outcome: Primary: Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up — 51.8; 49.0 percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: dasatinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Sep 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up	51.8; 49.0	—
SECONDARY Percent of Participants With MCyR At or Prior to 24 Months Follow-Up	58.3; 56.4; 57.3; 57.4	—
SECONDARY Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up	86.3; 85.4; 91.1; 87.4; 88.7; 86.2	—
SECONDARY Time to MCyR in Participants With MCyR at 6 Months Follow-Up	2.8; 2.8; 2.8; 2.8	—
SECONDARY Time to CHR in Participants With CHR at 6 Months Follow-Up	0.5; 0.5; 0.6; 0.7	—
SECONDARY Time to MCyR in Participants With MCyR at 24 Months Follow-Up	2.9; 2.8; 2.9; 2.9	—
SECONDARY Time to CHR in Participants With CHR At 24 Months Follow-Up	0.5; 0.5; 0.6; 0.7	—
SECONDARY Number of Participants With MCyR Whose Disease Progressed by 24 Months	5; 17; 6; 9	—
SECONDARY Number of Participants With CHR Whose Disease Progressed by 24 Months	18; 28; 22; 24	—
SECONDARY Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants	49; 49; 62; 48; 0; 1	—
SECONDARY Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up	75.2; 61.3; 70.3; 70.8; 64.8; 47.4	—
SECONDARY Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up	90.1; 93.9; 88.9; 85.1; 87.5; 83.8	—
SECONDARY Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose	72.4; 70.6; 73.6; 69.4; 77.0; 75.6	—
SECONDARY Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up	100; 86; 93; 85; 100; 89	—
SECONDARY Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up	83.6; 87.7; 77.4; 83.7; 71.7; 76.0	—
SECONDARY Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up	94.9; 92.8; 95.3; 97.4; 89.7; 92.8	—
SECONDARY Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up	57.2; 54.5; 56.1; 55.5; 87.7; 89.3	—
SECONDARY Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up	63.2; 61.3; 62.4; 62.1; 89.2; 90.2	—
SECONDARY Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants	77.4; 67.7; 72.2; 73.9; 66.6; 54.0	—
SECONDARY Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants	91.3; 93.6; 90.6; 88.1; 88.1; 86.2	—
SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up	58; 67; 73; 78; 32; 40	—
SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up	51; 133; 184; 11; 15; 26	—

Summary

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Men and women, 18 years or older
Adequate hepatic function
Adequate renal function
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria

Women who are pregnant or breastfeeding
Subjects who are eligible and willing to undergo transplantation during the screening period
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Uncontrolled or significant cardiovascular disease
Medications that increase bleeding risk
Medications that change heart rhythms
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
History of significant bleeding disorder unrelated to CML
Concurrent incurable malignancy other than CML
Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00123474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.