Overview

This trial is active, not recruiting.

Condition leukemia
Treatment dasatinib
Phase phase 2
Target BCR-ABL
Sponsor Bristol-Myers Squibb
Start date February 2009
End date September 2016
Trial size 139 participants
Trial identifier NCT00777036, 2008-002260-33, CA180-226

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dasatinib 60 mg/m² tablet every day (QD) [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFSO) QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit
dasatinib Sprycel (BMS-354825)
(Experimental)
Dasatinib 80 mg/m² tablet QD [with a maximum dose of 140 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFSO QD [with a maximum dose of 170 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit
dasatinib Sprycel (BMS-354825)
(Experimental)
Dasatinib 60 mg/m² tablet QD [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFSO QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit
dasatinib Sprycel (BMS-354825)

Primary Outcomes

Measure
Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study
time frame: Up to 5 years
Complete Hematologic Response (CHR) rate defined as the proportion of all treated subjects who achieve a confirmed CHR on study
time frame: Up to 5 years
Complete Cytogenetic Response (CCyR) rate, defined as the proportion of all treated subjects who achieve a CCyR on study
time frame: Up to 5 years

Secondary Outcomes

Measure
Complete Hematologic Response (CHR) rate for Cohort #1 and Cohort #3, defined as the proportion of all treated subjects who achieve a confirmed CHR on study
time frame: Up to 5 years
Major Cytogenetic Response (MCyR) rate for Cohort #2, defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study
time frame: Up to 5 years
Rates of best cytogenetic response
time frame: Up to 5 years
Time to Major Cytogenetic Response (MCyR) and duration of MCyR
time frame: Up to 5 years
Time to Complete Cytogenetic Response (CCyR) and duration of CCyR
time frame: Up to 5 years
Time to Complete Hematologic Response (CHR) and duration of CHR
time frame: Up to 5 years
Progression-free Survival (PFS), is defined as time from the first dosing date until the time Progressive Disease (PD) is first documented by the investigator or death
time frame: Up to 5 years
Disease free survival (DFS)
time frame: Up to 5 years
Overall Survival (OS) is defined as time from the first dosing date until the time of death
time frame: Up to 5 years
Rates of major and complete molecular response
time frame: Up to 5 years

Eligibility Criteria

Male or female participants up to 18 years old.

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 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

Additional Information

Official title A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Description Cohort 2 is closed to enrollment
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.