NCT03045328

Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL

An Open Label Phase 2 Trial of Venetoclax With Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Steven E. Coutre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label non-randomized two-center phase 2 study evaluating the safety and efficacy of concurrent therapy with ibrutinib and venetoclax in subjects with relapsed or refractory CLL/SLL.

Detailed description

The primary objective of this study is to evaluate the efficacy of concurrent therapy with ibrutinib and venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). The secondary objectives of this study are to define the safety, tolerability, and dose-limiting toxicity (DLT) within 28 days of completion of dose-escalation.

Conditions

• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
DRUG	Venetoclax	Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).

Timeline

• Start date: 2017-09-26
• Primary completion: 2020-05-19
• Completion: 2021-08-05
• First posted: 2017-02-07
• Last updated: 2021-09-29
• Results posted: 2021-09-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study