Study on Roginolisib, Venetoclax, and Rituximab for Treating Difficult or Returning Chronic Lymphocytic Leukemia (CLL)

Sponsor: Jennifer R. Brown, MD, PhD

Sponsor score: 0

ClinicalTrials ID:NCT06644183

This clinical trial is testing a new combination of three drugs—Roginolisib, Venetoclax, and Rituximab—to see if they are safe and effective in treating patients with Chronic Lymphocytic Leukemia (CLL) that has returned or not responded to previous treatments.

Patient Parameters

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Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment combination for Chronic Lymphocytic Leukemia (CLL) that has come back or not responded to other treatments. The study involves three drugs: Roginolisib, Venetoclax, and Rituximab. Roginolisib is a new type of drug that targets specific cancer cells, while Venetoclax and Rituximab are already approved for use in CLL. The study will compare the effects of adding Roginolisib to the standard treatment of Venetoclax and Rituximab.

Description

This study is divided into two phases: Phase I and Phase II. In Phase I, researchers will determine the safest dose of Roginolisib when combined with Venetoclax and Rituximab. In Phase II, participants will be randomly assigned to one of two groups: one group will receive all three drugs (Roginolisib, Venetoclax, and Rituximab), and the other group will receive only Venetoclax and Rituximab. This random assignment helps ensure that the results are fair and unbiased.

Participants will undergo various tests and procedures, including blood tests, scans, and bone marrow biopsies, to monitor their health and the treatment's effects. The study will last about 12 months, with follow-up visits for up to 5 years to track long-term outcomes.

The study is supported by iOnctura SA, which provides the Roginolisib drug, and the U.S. Department of Defense, which provides funding. Approximately 3-12 people will participate in Phase I, and 52 people will participate in Phase II.

Eligibility Criteria

Inclusion Criteria

Have Chronic Lymphocytic Leukemia (CLL) that has returned or not responded to previous treatments.
Have measurable disease, such as a high number of cancer cells in the blood or enlarged lymph nodes.
Have received at least two previous treatments for CLL, including a specific type of therapy.
Be willing to undergo bone marrow biopsies before and during treatment.
Be 18 years or older.
Be in relatively good health, with a performance status score of 0 to 2.
Have adequate blood cell counts and organ function based on specific tests.
Be willing to use effective birth control during the study and for a specified time after treatment.
Be able to understand and sign a consent form agreeing to participate in the study.
Be eligible to receive preventive treatments for infections as needed.

Exclusion Criteria

Have received Venetoclax or similar drugs in the last 6 months.
Have received a live vaccine within 30 days before starting the study.
Require ongoing treatment with high-dose steroids or immunosuppressants.
Have a history of certain aggressive forms of CLL.
Have not fully recovered from side effects of previous cancer treatments.
Are currently participating in another clinical trial for CLL.
Have allergies to the study drugs or similar medications.
Have a history of autoimmune diseases.
Are taking medications that strongly interact with Venetoclax.
Are pregnant or breastfeeding.
Have other cancers that require treatment interfering with the study.
Have difficulty swallowing or conditions affecting the digestive tract.
Have significant heart disease or other serious medical conditions.
Have active infections, including hepatitis or HIV, that could interfere with the study.
Have a history of alcohol or substance abuse.

Locations

FACILITY	ZIP	CITY	STATE
Dana-Farber Cancer Institute	02115	Boston	Massachusetts

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