Study on Zanubrutinib, Obinutuzumab, and Sonrotoclax for Untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT06849713
This clinical trial is testing a new combination of drugs to see if they can help patients with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) achieve undetectable levels of cancer cells.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if a combination of three drugs—zanubrutinib, obinutuzumab, and sonrotoclax—can effectively reduce cancer cells to undetectable levels in patients with CLL or SLL who have not received treatment before. The trial will involve about 40 participants and will monitor their response to the treatment over time. The duration of the treatment will vary depending on how well each participant responds, with follow-up for up to two years after the last participant joins the study.
Description
This study is a Phase II trial, which means it is testing the safety and effectiveness of a new drug combination. The drugs being tested are zanubrutinib, obinutuzumab, and sonrotoclax. While zanubrutinib and obinutuzumab are approved for treating CLL and SLL, the combination with sonrotoclax is not yet approved and is considered experimental.
Participants will receive the treatment for varying lengths of time, depending on how their cancer responds. Those who respond quickly may have a shorter treatment period, while those with a slower response may continue treatment longer. After completing the treatment, participants will be monitored for up to two years.
The study is open to about 40 participants who meet specific criteria, and it aims to provide insights into whether this new combination can help patients achieve better outcomes.
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of CLL or SLL.
- Need treatment according to specific medical guidelines.
- No previous systemic therapy for CLL or SLL, except for:
- Local radiation for symptoms.
- Short-term corticosteroids for disease control or other non-cancer reasons, with specific limits on dosage and duration.
- Must be 18 years or older.
- Must be in good general health, with a performance status score of 0, 1, or 2.
- Must have adequate organ and bone marrow function, as shown by specific blood test results.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.
- Men with partners of childbearing potential must agree to use condoms and effective contraception during and after treatment.
- Must be willing to sign a consent form and follow study procedures.
Exclusion Criteria
- Have a history of transformation from CLL or SLL to a more aggressive lymphoma.
- Have another active cancer or received treatment for another cancer within the last two years, unless it does not interfere with this study.
- Have uncontrolled illnesses that could affect study participation, such as severe infections or heart problems.
- Have received a live vaccine within 28 days before starting the study treatment.
- Have active infections or a history of severe bleeding disorders.
- Have had major surgery within four weeks before the study or plan to have major surgery during the study.
- Have a history of certain viral infections, unless well-controlled.
- Have conditions that prevent swallowing or absorbing oral medications.
- Are participating in another investigational drug trial.
- Are taking certain medications that could interfere with the study drugs.
- Have known allergies to the study drugs or their components.
- Are pregnant or breastfeeding, due to potential risks to the baby.
- Have uncontrolled high blood pressure.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.