At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
CTL019biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia
In Brief
A Phase 2 clinical trial evaluating CTL019 for B-cell Acute Lymphoblastic Leukemia. Completed, enrolled 80 participants across 23 sites in 11 countries.
Detailed Summary
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Acute Lymphoblastic Leukemia
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Norway, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedMay 2015
Primary CompletionJan 2020
Study CompletionNov 2022
TodayJul 2026
First PostedMay 6, 2015
Enrollment StartApr 8, 2015
Primary CompletionJan 21, 2020
Study CompletionNov 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.2 years ago
Interventions
CTL019biological
Tisagenlecleucel was administered as a single iv infusion. Dose: 2.0 to 5.0x10\^6 tisagenlecleucel per kg body weight (for patients ≤ 50 kg) or 1.0 to 2.5x10\^8 tisagenlecleucel (for patients \>50 kg).