NCT03054896

A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome

Venetoclax Plus Dose-adjusted R-EPOCH or R-CHOP for Richter's Syndrome

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating the combination of a study drug, venetoclax, and a standard chemotherapy regimen, R-EPOCH or R-CHOP, as a possible treatment for Richter's Syndrome. The drugs involved in this study are: * Venetoclax * R-EPOCH: * Rituximab * Etoposide * Prednisone * Vincristine Sulfate (Oncovin) * Cyclophosphamide * Doxorubicin Hydrochloride (Hydroxydaunomycin) * R-CHOP: * Rituximab * Cyclophosphamide Vincristine * Doxorubicin Hydrochloride (Hydroxydaunomycin) * Sulfate (Oncovin) * Prednisone

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. Tumor cells from patients with Richter's Syndrome are often resistant to chemotherapy. One reason for this may be that a protein called BCL-2 can prevent cancer cells from dying after being exposed to chemotherapy. Venetoclax is an oral drug that specifically targets BCL-2. It has already been shown to be highly effective at killing tumor cells from CLL patients whose cells are resistant to chemotherapy, leading to its FDA (the U.S. Food and Drug Administration) approval for these patients. A small number of patients with Richter's Syndrome have been treated with venetoclax as a single drug, and some of these patients had improvement of their cancer with this treatment. In this research study, the investigators are looking to see whether adding venetoclax to a standard chemotherapy regimen, R-EPOCH or R-CHOP, will help this chemotherapy work better to more effectively kill tumor cells in patients with Richter's Syndrome. Venetoclax is not approved for Richter's Syndrome or for use in combination with chemotherapy, which is why its use in this trial is considered to be investigational.

Conditions

• Richter Syndrome

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax is an Antineoplastic Agent; BCL-2 Inhibitor
OTHER	DA-EPOCH-R	Intensive chemotherapy regiment
OTHER	R-CHOP	Intensive chemotherapy regiment

Timeline

• Start date: 2017-03-08
• Primary completion: 2024-12-01
• Completion: 2027-12-01
• First posted: 2017-02-16
• Last updated: 2025-08-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study