Phase 2
N=130
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00777036 ↗Enrolled (actual)
130
Serious AEs
45.3%
Results posted
Jan 2018
Primary outcome: Primary: Major Cytogenetic Response (MCyR) Rate — 89.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Cytogenetic Response (MCyR) Rate |
89.7 | — |
| PRIMARY Complete Hematologic Response (CHR) Rate |
29.4 | — |
| PRIMARY Complete Cytogenetic Response (CCyR) Rate |
94.0 | — |
| SECONDARY Major Cytogenetic Response (MCyR) Rate in Cohort 2 |
52.9 | — |
| SECONDARY Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 |
93.1; 96.4 | — |
| SECONDARY Rate of Best Cytogenetic Response |
82.8; 29.4; 94.0; 96.1; 90.9; 6.9 | — |
| SECONDARY Time to Major Cytogenetic Response (MCyR) |
3.1; 1.6; 3.0; 3.3; 3.0 | — |
| SECONDARY Duration of Major Cytogenetic Response (MCyR) |
NA; 11.2; NA; NA; NA | — |
| SECONDARY Time to Complete Cytogenetic Response (CCyR) |
3.9; 1.6; 5.6; 5.7; 5.6 | — |
| SECONDARY Duration of Complete Cytogenetic Response (CCyR) |
NA; NA; NA; NA; NA | — |
| SECONDARY Progression-Free Survival (PFS) |
NA; 6.67; NA; NA; NA | — |
| SECONDARY Time to Complete Hematologic Response (CHR) |
0.7; 2.5; 1.2; 1.2; 1.0 | — |
| SECONDARY Duration of Complete Hemotologic Response (CHR) |
NA; NA; NA; NA; NA | — |
| SECONDARY Disease-Free Survival |
NA; NA; NA; NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; 13.63; NA; NA; NA | — |
| SECONDARY Major Molecular Response (MMR) Rate |
69.0; 29.4; 84.5; 90.2; 75.8 | — |
| SECONDARY Complete Molecular Response (CMR) Rate |
27.6; 11.8; 42.9; 49.0; 33.3 | — |
| SECONDARY Major Cytogenetic Response (MCyR) Rate up to 2 Years |
89.7; 58.8; 96.4; 98.0; 93.9; 89.7 | — |
| SECONDARY Complete Cytogenetic Response (CCyR) Rate up to 2 Years |
75.9; 41.2; 92.9; 96.1; 87.9; 82.8 | — |
| SECONDARY Major Molecular Response (MMR) Rate up to 7.5 Years |
41.4; 29.4; 52.4; 56.9; 45.5; 55.2 | — |
| SECONDARY Complete Molecular Response (CMR) Rate up to 7.5 Years |
6.9; 5.9; 8.3; 9.8; 6.1; 17.2 | — |
Summary
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- CP-CML who prove resistant or intolerant to imatinib (Cohort 1)
- Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)
- Newly diagnosed, treatment naive CP-CML (Cohort 3)
- Lansky or Karnofsky scale >50
- Life expectancy ≥12 weeks
- Adequate hepatic and renal function
- Written informed consent
- Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
- Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
- Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
- Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
- Target Population for the PK substudy subjects must meet relevant inclusion criteria
Exclusion Criteria
- Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
- Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
- Isolated extramedullary disease
- Prior therapy with Dasatinib
- Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria
- Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy
Other inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00777036). 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.