Rituximab + HDMP Debulking Before Venetoclax for Chronic B-Cell Leukemia
Trial Summary
What is the purpose of this trial?
This trial is testing if using rituximab and high dose methylprednisolone together can reduce cancer cells in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The goal is to make venetoclax safer by lowering the risk of a serious side effect. Patients will be divided into groups based on their risk and treated accordingly. Rituximab is effective in treating various lymphomas and leukemias.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like moderate or strong CYP3A inhibitors or inducers within 7 days before starting venetoclax, and you should avoid grapefruit, Seville oranges, and star fruit within 3 days before starting venetoclax.
What data supports the effectiveness of the drug combination of rituximab and venetoclax for chronic B-cell leukemia?
Research shows that combining rituximab with venetoclax can be effective for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In studies, this combination provided longer progression-free survival (the time during which the disease does not get worse) compared to venetoclax alone, and many patients experienced significant and lasting responses.12345
Is the combination of Rituximab and Venetoclax safe for treating chronic lymphocytic leukemia?
How is the drug combination of Rituximab, HDMP, and Venetoclax unique for treating chronic B-cell leukemia?
This treatment is unique because it combines Rituximab and Venetoclax, which have shown synergistic effects in prolonging progression-free survival, with High-Dose Methylprednisolone (HDMP) for debulking (reducing tumor size) before starting Venetoclax. This approach may enhance the effectiveness of Venetoclax, especially in patients who have relapsed or have refractory chronic lymphocytic leukemia.12357
Research Team
Choi Michael, MD
Principal Investigator
University of California, San Diego
Eligibility Criteria
Adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have had at least one prior treatment but not venetoclax in the last 6 months, can join. They must be generally healthy, understand the study, and agree to use contraception. Excluded are those with severe allergies to monoclonal antibodies, recent heart attacks, uncontrolled infections or other cancers that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Debulking Treatment
Patients receive HDMP + Rituximab for 1 cycle to reduce tumor burden before starting venetoclax
Venetoclax Ramp-up
Patients begin venetoclax dose ramp-up after achieving low tumor burden, with a schedule according to venetoclax package insert
Venetoclax Maintenance
Patients continue Venetoclax 400 mg (or highest tolerated dose) for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- High-Dose Methylprednisolone
- Rituximab
- Venetoclax
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor