Pirtobrutinib + Venetoclax + Rituximab for Waldenström's Macroglobulinemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a new combination of treatments—pirtobrutinib, venetoclax, and rituximab—can effectively treat Waldenström's macroglobulinemia (WM) and lymphoplasmacytic lymphoma (LPL), rare types of blood cancer. The goal is to determine if this combination can manage symptoms and slow disease progression. Individuals who have not received previous treatment for WM or LPL and experience symptoms like anemia or nerve problems related to the disease might be suitable candidates. Joining the trial offers the opportunity to try a promising new therapy before it becomes widely available. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude participants who require ongoing use of certain drugs that affect liver enzymes (CYP3A inducers or inhibitors) or P-gp inhibitors. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is investigating the safety of combining three drugs—pirtobrutinib, venetoclax, and rituximab—for individuals with Waldenström's macroglobulinemia (WM). Earlier studies have shown that venetoclax alone was safe and effective for patients whose WM had returned, yielding good results without serious side effects.
Additionally, when pirtobrutinib and venetoclax were used together in previously treated patients, they were well-tolerated. This suggests that using these drugs together might be manageable for patients.
Although this specific combination remains under study, the safe use of venetoclax and pirtobrutinib in other contexts is reassuring. However, it is important to note that this research is ongoing, and participants will be closely monitored for any side effects during the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Pirtobrutinib, Venetoclax, and Rituximab for treating Waldenström's Macroglobulinemia because it offers a novel approach compared to standard therapies like chemotherapy or single-agent immunotherapy. Pirtobrutinib is a next-generation BTK inhibitor that targets cancer cells more precisely, potentially leading to fewer side effects and improved effectiveness. Venetoclax works by inducing cancer cell death through a different pathway, offering a complementary mechanism to Pirtobrutinib. Rituximab, a well-known antibody, enhances the treatment by targeting and killing cancerous B-cells. This combination could provide a more comprehensive attack on the disease, offering hope for better outcomes.
What evidence suggests that this trial's treatments could be effective for Waldenström's macroglobulinemia?
This trial will evaluate the combination of pirtobrutinib, venetoclax, and rituximab for treating Waldenström's macroglobulinemia (WM) and lymphoplasmacytic lymphoma (LPL). Studies have shown that this combination looks promising. In earlier small studies, patients treated with venetoclax showed positive results, especially those with recurrent or hard-to-treat cancer. Research also shows that using pirtobrutinib and venetoclax together was effective in patients who had already received treatment for WM, with many experiencing significant improvement. Additionally, BTK inhibitors like pirtobrutinib have been found to work well in both newly diagnosed and previously treated patients. These findings suggest that this combination of drugs could be effective for WM and LPL.12356
Who Is on the Research Team?
M. Lia Palomba, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with Waldenström's macroglobulinemia (WM) or lymphoplasmacytic lymphoma (LPL), including MALT Lymphoma. Specific eligibility criteria are not provided, but typically include factors like age, disease stage, and overall health.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of pirtobrutinib, venetoclax, and rituximab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pirtobrutinib
- Rituximab
- Venetoclax
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois