Phase 3
N=611
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
Myeloid Leukemia, Chronic, Accelerated Phase · Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Bottom Line
View on ClinicalTrials.gov: NCT00123487 ↗Enrolled (actual)
611
Serious AEs
76.2%
Results posted
Oct 2014
Primary outcome: Primary: Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population — 48.0; 47.9 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
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population |
48.0; 47.9 | — |
| SECONDARY Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population |
50.7; 49.8 | — |
| SECONDARY Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population |
66.5; 67.9; 28.0; 28.4; 42.4; 32.1 | — |
| SECONDARY Median Time to Major Hematologic Response (MaHR) - Randomized Population |
1.9; 1.9; 1.9; 1.9 | — |
| SECONDARY Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study |
21.1; 24.7 | — |
| SECONDARY Percent of Participants With Overall Hematologic Response - Randomized Population |
59.2; 57.4; 60.1; 59.0 | — |
| SECONDARY Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population |
94; 96; 108; 110; 53; 50 | — |
| SECONDARY Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population |
36.9; 39.3; 41.5; 41.3 | — |
| SECONDARY Number of Participants With Best Cytogenic Response (CyR) - Randomized Population |
89; 84; 97; 98; 24; 36 | — |
| SECONDARY Median Progression Free Survival (PFS) - Randomized Population |
7.8; 10.4 | — |
| SECONDARY Median Overall Survival (OS) - Randomized Population |
17.7; 22.4 | — |
| SECONDARY Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population |
29.5; 33.1; 24.1; 26.6; 19.8; 20.5 | — |
| SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants |
203; 186; 66; 63; 228; 236 | — |
| SECONDARY Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants |
129; 114; 2; 2; 64; 79 | — |
| SECONDARY Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations |
64; 72; 167; 164; 132; 142 | — |
| SECONDARY Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants |
28; 26; 14; 20; 14; 9 | — |
| SECONDARY Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants |
4; 7; 13; 15; 88; 65 | — |
| SECONDARY Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants |
252; 239; 21; 26; 7; 5 | — |
Summary
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic 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
- Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate
- Men and women, 18 years of age 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
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
Exclusion Criteria
- Women who are pregnant or breastfeeding
- 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
- Prior therapy with BMS-35425
- 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
Data sourced from ClinicalTrials.gov (NCT00123487). 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.