At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 69 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.
Phase IIIb Study for Relapsed/Refractory Pediatric/Young Adult Acute Lymphoblastic Leukemia Patients to be Treated With CTL019
In Brief
A Phase 3 clinical trial evaluating CTL019 for Acute Lymphoblastic Leukemia. Completed, enrolled 69 participants across 11 sites in 9 countries.
Detailed Summary
This is a single arm, open-label, multi-center, phase III B study to determine the safety and efficacy of CTL019 in pediatric/young adult patients with r/r B-cell Acute Lymphoblastic Leukemia (ALL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesAustria, Belgium, Canada, France, Germany, Italy, Japan, Norway, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartApr 2017
Primary CompletionOct 2020
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartApr 24, 2017
Primary CompletionOct 13, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.2 years ago
Interventions
CTL019biological
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)