Duvelisib + Venetoclax for Chronic Lymphocytic Leukemia

Recruiting at6 trial locations

Overseen by Matthew S. Davids

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research study is assessing a new drug, duvelisib, in combination with a drug that is already FDA approved, venetoclax, as a possible treatment for participants with CLL or those with Richter's Syndrome

Research Team

Matthew S. Davids

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma needing treatment, or those with Richter's Syndrome after at least one prior therapy (not applicable for Richter's). Must have adequate blood counts, liver and kidney function, agree to use contraception, and be able to consent. Excludes those with central nervous system involvement, recent transplants or active infections, certain virus histories, major surgery within 4 weeks, gastrointestinal disease requiring therapy, pregnancy/breastfeeding individuals.

Inclusion Criteria

I am 18 years old or older.

My liver is working well.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

I am taking less than 20 mg of corticosteroids daily.

I have a lung condition or severe breathing problems.

Known hypersensitivity to duvelisib and/or its excipients

Treatment Details

Interventions

• Duvelisib (PI3K Inhibitor)
• Venetoclax (BCL-2 Inhibitor)

Trial Overview The trial is testing a new drug called duvelisib in combination with an FDA-approved drug venetoclax. It aims to treat participants who have relapsed or are not responding well to previous treatments for CLL/SLL/RS. The study will assess the effectiveness and safety of this drug combo.

Participant Groups

Group I: Duvelisib +Venetoclax, Experimental Treatment 2 Interventions

Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added. * Duvelisib will be administered orally twice daily * Venetoclax will be administered orally daily * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

Secura Bio, Inc.

Industry Sponsor

Trials

9

Recruited

200+