NCT02640833

A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor

A Phase 1b/2 Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not previously received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2 portion of the study will preliminarily evaluate efficacy, and expand the toxicity evaluation.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Duvelisib	Duvelisib will be taken continuously. This is a defining dose study, therefore the dose of Duvelisib may change.
DRUG	Venetoclax	Venetoclax will be taken continuously. This is a defining dose study, therefore the dose of Venetoclax will change.

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-01-01
• Completion: 2021-02-01
• First posted: 2015-12-29
• Last updated: 2016-07-26

Locations

10 sites across 1 country: United States