Phase 2
N=54
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
Chronic Myelogenous Leukemia · Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01030718 ↗Enrolled (actual)
54
Serious AEs
61.1%
Results posted
Dec 2010
Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation — 30; 11; 13; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dasatinib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation |
30; 11; 13; 13; 9; 11 | — |
| SECONDARY Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response |
77; 61; 100; 63; 44; 92 | — |
| SECONDARY Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response |
27; 38; 0; 18; 25; 0 | — |
| SECONDARY Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response |
54; 33; 100; 46; 22; 100 | — |
| SECONDARY Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR) |
169 | — |
| SECONDARY Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR) |
215; 82 | — |
| SECONDARY Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR) |
— | — |
| SECONDARY Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR) |
96.5 | — |
| SECONDARY Participants With CML-CP: Time to Major Cytogenetic Response (MCyR) |
169 | — |
| SECONDARY Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR) |
85; 85 | — |
| SECONDARY Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR) |
— | — |
| SECONDARY Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR) |
85 | — |
| SECONDARY Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR) |
93; 89; 100 | — |
| SECONDARY Participants With CML-AP/BP: Percentage of Participants With Hematologic Response |
73; 75; 67; 73; 75; 67 | — |
| SECONDARY Participants With Ph+ ALL: Percentage of Participants With Hematologic Response |
69; 56; 100; 46; 33; 75.5 | — |
| SECONDARY Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL |
12.5; 89; 98.5 | — |
| SECONDARY Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL |
1160; 373 | — |
| SECONDARY Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL |
45.5; 59 | — |
| SECONDARY Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL |
102.5 | — |
| SECONDARY Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL |
38.5; 13 | — |
| SECONDARY Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL |
104 | — |
| SECONDARY Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement |
28; 11; 10; 12; 7; 6 | — |
| SECONDARY Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS) |
1; 1; 7; 2; 1; 3 | — |
| SECONDARY Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling |
— | — |
Summary
To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)
Eligibility Criteria
Inclusion Criteria
- Subjects who were eligible and completed the previous Phase I and II study (CA180031/NCT00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject
Exclusion Criteria
- Women who are pregnant or breastfeeding
- Subjects who are eligible and willing to undergo transplantation at pre-study
- Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II study (CA180031/NCT00337454)
Data sourced from ClinicalTrials.gov (NCT01030718). 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.