Study on Duvelisib and Venetoclax for Treating Relapsed or Hard-to-Treat CLL, SLL, or Richter's Syndrome
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT03534323
This clinical trial is exploring a new treatment using the drug duvelisib, combined with the already approved drug venetoclax, to help patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Richter's Syndrome that have not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to test a new combination of drugs, duvelisib and venetoclax, to see if they can effectively treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Richter's Syndrome that have either not responded to previous treatments or have returned after treatment. Duvelisib is a new drug being studied, while venetoclax is already approved for use. The study will first determine the safe dose of these drugs together and then evaluate how well they work in treating these conditions.
Description
This study is divided into two phases: Phase I and Phase II.
In Phase I, researchers will test the safety of using duvelisib in combination with venetoclax. Duvelisib is a capsule taken by mouth that works by blocking a protein important for the survival of CLL cells. Venetoclax is a tablet that targets a protein helping cancer cells survive. The goal is to find a safe dose of venetoclax to use with duvelisib and to observe any side effects.
In Phase II, the study will focus on how effective the combination of duvelisib and venetoclax is in treating patients with CLL or Richter's Syndrome. Researchers will look at how well the treatment works in reducing cancer cells and improving patient outcomes.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that requires treatment, or have Richter's Syndrome.
- The disease must have worsened during or after at least one previous treatment for CLL/SLL. This does not apply to Richter's Syndrome.
- Must be 18 years or older.
- Must be in relatively good health, with a performance status score of 0 to 2.
- Must meet certain blood count levels unless there is significant bone marrow involvement.
- Must have adequate liver and kidney function as determined by specific blood tests.
- Women of childbearing potential and men must agree to use effective contraception during the study.
- Must be able to understand and sign a consent form agreeing to participate in the study.
Exclusion Criteria
- Previous treatment with either venetoclax or duvelisib.
- Receiving cancer treatment within two weeks of starting the study, with some exceptions.
- Confirmed involvement of the central nervous system by cancer.
- Recent stem cell transplant or active graft vs. host disease.
- Active infections requiring IV antibiotics or uncontrolled infections.
- Known history of HIV, hepatitis B, or hepatitis C.
- Major surgery within four weeks of starting the study.
- Active gastrointestinal diseases or significant heart conditions.
- Pregnant or breastfeeding women.
- Use of certain medications that affect how the study drugs work.
- Unable to swallow capsules or have conditions affecting digestion.
- History of alcohol abuse or chronic liver disease.
- Known allergies to duvelisib or its ingredients.
- Recent treatment for tuberculosis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami- Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Northern Light Eastern Maine Medical Center | 04412 | Brewer | Maine |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Boston Medical Center | 02118 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Berkshire Medical Center | 01201 | Pittsfield | Massachusetts |
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