Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT01088984

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

43

Starts

2010-08-01

Expected to finish

2011-08-01

Last updated by the study team

2016-05-23

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Teva Investigational Site 17 — Orange, California, United States
• Teva Investigational Site 12 — San Diego, California, United States
• Teva Investigational Site 10 — St. Petersburg, Florida, United States
• Teva Investigational Site 8 — Baltimore, Maryland, United States
• Teva Investigational Site 16 — Boston, Massachusetts, United States
• Teva Investigational Site 9 — Detroit, Michigan, United States
• Teva Investigational Site 1 — Jackson, Mississippi, United States
• Teva Investigational Site 5 — Kansas City, Missouri, United States
• Teva Investigational Site 14 — St Louis, Missouri, United States
• Teva Investigational Site 15 — New York, New York, United States
• Teva Investigational Site 18 — Portland, Oregon, United States
• Teva Investigational Site 11 — Hershey, Pennsylvania, United States
• Teva Investigational Site 7 — Philadelphia, Pennsylvania, United States
• Teva Investigational Site 19 — Memphis, Tennessee, United States
• Teva Investigational Site 3 — Dallas, Texas, United States
• Teva Investigational Site 4 — Fort Worth, Texas, United States
• Teva Investigational Site 13 — Houston, Texas, United States
• Teva Investigational Site 2 — Seattle, Washington, United States
• Teva Investigational Site 6 — Milwaukee, Wisconsin, United States
• Teva Investigational Site 300 — Herston, Australia
• Teva Investigational Site 301 — Parkville, Australia
• Teva Investigational Site 302 — Randwick, Australia
• Teva Investigational Site 520 — Minsk, Belarus
• Teva Investigational Site 615 — Barretos-SP, Brazil
• Teva Investigational Site 616 — Caxias do Sul, Brazil

Full record on ClinicalTrials.gov

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