At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 93 enrolled
Drug / intervention
Blinatumomabbiological
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 Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
In Brief
A Phase 2 clinical trial evaluating Blinatumomab for Acute Lymphoblastic Leukemia. Completed, enrolled 93 participants across 30 sites in 7 countries.
Detailed Summary
The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesAustria, Canada, France, Germany, Italy, Netherlands, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartJan 2012
Primary CompletionAug 2014
Study CompletionMay 2016
TodayJul 2026
First PostedNov 16, 2011
Enrollment StartJan 1, 2012
Primary CompletionAug 1, 2014
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.6 years ago
Interventions
Blinatumomabbiological
Administered by continuous intravenous infusion