At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
Bendamustinedrug
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.
An Open-Label Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 18, 2010·Updated May 23, 2016
In Brief
A Phase 2 clinical trial evaluating Bendamustine for Leukemia. Completed, enrolled 43 participants across 50 sites in 12 countries.
Detailed Summary
The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended pediatric dose for the treatment of pediatric patients with relapsed or refractory acute leukemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesAustralia, Belarus, Brazil, Canada, Israel, Mexico, New Zealand, Poland, Russia, Singapore, South Korea, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartAug 2010
Primary CompletionAug 2011
TodayJul 2026
First PostedMar 18, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.3 years ago
Interventions
Bendamustinedrug