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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Venetoclax Plus Dose-adjusted EPOCH-R for Richter's Syndrome

Brief Summary:

This research study is evaluating the combination of a study drug, venetoclax, and a standard chemotherapy regimen, EPOCH-R, as a possible treatment for Richter's Syndrome.

The drugs involved in this study are:

  • Venetoclax
  • EPOCH-R:
  • Etoposide
  • Prednisone
  • Vincristine Sulfate (Oncovin)
  • Cyclophosphamide
  • Doxorubicin Hydrochloride (Hydroxydaunomycin)
  • Rituximab

Detailed Summary:

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, 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.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Rate of Complete Response by 2008 IW-CLL Response Criteria [ Time Frame: 2 years ]

Complete Response Rate


Original Primary Outcome: Rate of Complete Response by 2008 IW-CLL Response Criteria [ Time Frame: 2 years ]

Current Secondary Outcome:

  • Partial Response Rate by 2008 IW-CLL Response Criteria [ Time Frame: 2 years ]
    Partial Response Rate
  • Progression Free Survival [ Time Frame: 2 years ]
    PFS
  • Overall Survival Rate [ Time Frame: 2 years ]
    OS
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    Treatment-related AEs


Original Secondary Outcome:

  • Partial Response Rate by 2008 IW-CLL Response Criteria [ Time Frame: 2 years ]
  • Progression Free Survival [ Time Frame: 2 years ]
  • Overall Survival Rate [ Time Frame: 2 years ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]


Information By: Dana-Farber Cancer Institute

Dates:
Date Received: February 10, 2017
Date Started: March 8, 2017
Date Completion: September 1, 2023
Last Updated: March 15, 2017
Last Verified: March 2017