Trials / Completed
CompletedNCT01088984
Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
An Open-Label Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 1 Year – 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bendamustine |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2010-03-18
- Last updated
- 2016-05-23
- Results posted
- 2014-10-01
Locations
50 sites across 12 countries: United States, Australia, Belarus, Brazil, Canada, Israel, Mexico, New Zealand, Poland, Russia, Singapore, South Korea
Source: ClinicalTrials.gov record NCT01088984. Inclusion in this directory is not an endorsement.