NCT03181126

A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

A Phase 1 Dose Escalation, Open-Label Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric participants with relapsed/refractory acute lymphoblastic leukemia (ALL) or relapsed/refractory lymphoblastic lymphoma. A safety expansion cohort of approximately 20 patients may be enrolled in addition to the 50 participants in dose-escalation cohort.

Conditions

• Acute Lymphoblastic Leukemia (ALL)
• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Navitoclax	tablet
DRUG	Chemotherapy	peg-asparaginase (or other form of asparaginase, per local standard of care (intravenous) + vincristine (intravenous) + dexamethasone (oral) + tyrosine kinase inhibitor (TKI) (if applicable, oral)
DRUG	Venetoclax	tablet

Timeline

• Start date: 2017-11-27
• Primary completion: 2020-11-11
• Completion: 2020-11-14
• First posted: 2017-06-08
• Last updated: 2021-10-14

Locations

15 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study