Date: 2017-12-09
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 2017 American Society of Hematology Annual Meeting
Company: BMS (USA - NY)
Product: Sprycel® (dasatinib)
Action
mechanism: tyrosine kinase inhibitor
Disease: newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)
Therapeutic
area: Cancer - Oncology
Country: Australia, Canada, Italy, Puerto Rico, UK, USA
Trial
details:
- The purpose of the CA180-372 study is to determine whether dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia. Patients received dasatinib 60 mg/m2 tablets or powder for oral suspension, once daily, in addition to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone for two years or until the occurrence of unacceptable toxicity.Two patients discontinued Sprycel® due to toxicity, one due to allergy and one due to prolonged thrombocytopenia. Primary toxicities of any causality included hematological toxicity such as grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%) and bacteremia (24.5%). Non-hematologic, non-infectious grade 3 or 4 adverse events (AEs) attributed to dasatinib and reported in more than 10% of patients were limited to elevated alanine aminotransferase (21.7%) and aspartate transaminase (10.4%). Other grade 3 or 4 AEs attributed to dasatinib were pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%) and cardiac failure (0.8%). No events of pulmonary hypertension or pulmonary arterial hypertension were reported. Seven deaths occurred during protocol therapy, with five patients receiving chemotherapy (three due to sepsis, one due to pneumonia and one with unknown cause) and two, transplant-related. (NCT01460160)
Latest
news:
- • On December 9, 2017, BMS announced data from the phase 2 CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia treated with Sprycel® (dasatinib) added to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone. The combination demonstrated an event-free survival (EFS) rate, the study’s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival (OS) rate of 91.5% (95% CI: 84.2 to 95.5) at three years. Sprycel® and chemotherapy were generally well-tolerated in pediatric Ph+ ALL patients. Results have been presented at the 2017 American Society of Hematology Annual Meeting in Atlanta, Georgia.
- Patients treated in the study (n=106), all aged younger than 18 years, received continuous daily Sprycel beginning at day 15 of induction chemotherapy. All treated patients achieved complete remission. Patients who had evidence of minimal residual disease (MRD) ?0.05% at the end of the first block of treatment (day 78), and those with MRD 0.005% to 0.05% who remained MRD-positive at any detectable level after three additional high-risk chemotherapy blocks, were eligible for hematopoietic stem cell transplantation (HSCT) in first remission. Among treated patients, 19 met this criteria, and 15 (14.2%) received HSCT. The remaining 85.8% of patients received Sprycel plus chemotherapy for two years.
Is
general: Yes
