NCT03547115

A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML

Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: MEI Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML

Detailed description

This is a Phase 1, open-label, 3 + 3 dose escalation and expansion study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of prior standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML. Escalation to the next higher dose level will depend on demonstrated safety and tolerability at each dose level.

Conditions

• Follicular Lymphoma (FL)
• Mantle Cell Lymphoma (MCL)
• Marginal Zone Lymphoma (MZL)
• Small Lymphocytic Lymphoma (SLL)
• Chronic Lymphocytic Leukemia (CLL)
• Diffuse Large B-cell Lymphoma (DLBCL)
• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	voruciclib monotherapy	Voruciclib will be administered orally
DRUG	voruciclib and venetoclax	Voruciclib and Venetoclax will be administered orally

Timeline

• Start date: 2018-05-31
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2018-06-06
• Last updated: 2026-03-17

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study