A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Recruitment completed


An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

Venetoclax ist a small molecule binding to  the protein BCL-2. By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows down progression of the disease. Venetoclax is administered orally once daily with or without chemotherapy. 

Main inclusion criteria

  • Patients up to 25 years
  • Relapsed or refractory malignancies
  • only relapsed or refractory leukemia and lymphoma are eligible at trial site Freiburg 



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