Study on Venetoclax and Obinutuzumab Followed by Epcoritamab for Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT07218510
This clinical trial is exploring a new treatment approach for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received any prior treatment. The study combines the standard treatment of venetoclax and obinutuzumab with a new drug, epcoritamab, to see if it can improve patient outcomes.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to test the effects of a treatment combination for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not been treated before. The treatment includes venetoclax, which helps stop cancer cell growth, and obinutuzumab, which helps the immune system attack cancer cells. Epcoritamab, a new drug, is added to see if it can make the treatment more effective. Researchers hope this combination will lead to better and longer-lasting responses in patients.
Description
The main goal of this study is to see how effective the combination of venetoclax and obinutuzumab followed by venetoclax and epcoritamab is in treating newly diagnosed CLL/SLL. Researchers will measure how many patients achieve a complete response with no minimal residual disease after 12 cycles of treatment.
Secondary goals include evaluating the safety of the treatment and how well patients respond overall, how long they live without the disease getting worse, and their overall survival.
The study will also explore how the treatment affects certain immune cells and how specific genetic markers relate to treatment outcomes.
Patients will receive obinutuzumab through an IV on specific days during the first six cycles, venetoclax orally daily after the first cycle, and epcoritamab through an injection under the skin starting from the seventh cycle. Treatment cycles repeat every 28 days for up to 12 cycles, unless the disease progresses or side effects become unacceptable. After 12 cycles, patients with certain responses may continue receiving epcoritamab for additional cycles.
Throughout the study, patients will have blood tests, imaging scans, and possibly bone marrow tests to monitor their response to the treatment. After completing the treatment, patients will have follow-up visits to check their health and disease status for up to five years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Have not received any prior treatment for CLL/SLL, except for steroids or rituximab for autoimmune issues.
- Show signs that treatment is needed, such as significant weight loss, extreme fatigue, fevers, night sweats, worsening anemia, or enlarged lymph nodes or spleen.
- Be able to swallow pills.
- Have adequate blood cell counts and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after treatment.
- Men must agree to use condoms during and after treatment.
Exclusion Criteria
- Chronic use of high-dose steroids.
- Recent major surgery.
- Uncontrolled bleeding disorders.
- Recent live vaccinations.
- Transformation of CLL to a more aggressive form of lymphoma.
- Current involvement of the central nervous system by CLL.
- History of certain serious infections or other cancers, unless treated and inactive for at least two years.
- Active infections like hepatitis B or C, unless under control.
- HIV-positive patients may participate if on stable treatment and meeting other criteria.
- Pregnant or breastfeeding women.
- Any condition that might make participation unsafe or difficult.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| City of Hope at Long Beach Elm | 90813 | Long Beach | California |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
| City of Hope Atlanta Cancer Center | 30265 | Newnan | Georgia |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | 10016 | New York | New York |
| Medical College of Wisconsin | 53226 | Milwaukee | Wisconsin |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.