A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Leukemia
Neuroblastoma
Non-Hodgkin Lymphoma
0 - 25 Years, Male and Female
M13-833 (primary)
NCI-2017-02027
2017-000439-14
Summary
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.
Eligibility
- Participants must have relapsed or refractory cancer.
- Participants must have adequate hepatic and kidney function.
- Participants less than or equal to 16 years of age must have performance status of Lansky greater than or equal to 50% and participants greater than 16 years of age must have performance status of Karnofsky greater than or equal to 50%.
- Participants with solid tumors (with the exception of neuroblastoma) must have adequate bone marrow function in Part 1.
- For the fifth cohort during Part 2 Cohort Expansion, participants with solid tumors must have evidence of BCL-2 expression (except participants with TCF3-HLF ALL).
Treatment Sites in Georgia
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org
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