Daratumumab + Ibrutinib for Chronic Lymphocytic Leukemia
Trial Summary
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. However, you cannot participate if you require certain medications like warfarin or strong CYP3A inhibitors. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Daratumumab and Ibrutinib for treating Chronic Lymphocytic Leukemia?
Ibrutinib has shown effectiveness as a first-line treatment for chronic lymphocytic leukemia, improving outcomes like progression-free survival when used alone or with other drugs. This suggests potential benefits when combined with Daratumumab, although specific studies on this combination are not mentioned.12345
Is the combination of Daratumumab and Ibrutinib safe for treating chronic lymphocytic leukemia?
What makes the drug combination of Daratumumab and Ibrutinib unique for treating chronic lymphocytic leukemia?
The combination of Daratumumab and Ibrutinib is unique because it combines two different mechanisms: Daratumumab targets CD38 on cancer cells, while Ibrutinib inhibits Bruton's tyrosine kinase, which is crucial for cancer cell survival. This dual approach may offer enhanced effectiveness compared to using either drug alone.110111213
What is the purpose of this trial?
This phase Ib trials studies the side effects of daratumumab and ibrutinib and how well they work in treating patients with symptomatic chronic lymphocytic leukemia. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daratumumab and ibrutinib may work better in treating patients with chronic lymphocytic leukemia.
Research Team
Jennifer Woyach, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with symptomatic chronic lymphocytic leukemia (CLL) who need treatment and haven't had chemotherapy, immunotherapy, or targeted therapy before. Participants must have certain blood counts, no history of severe allergic reactions to monoclonal antibodies, no active infections like hepatitis B/C or HIV, and not be pregnant or breastfeeding. They should also not have any serious heart conditions or other illnesses that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daratumumab IV and ibrutinib PO for up to 12 courses, each lasting 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Daratumumab
- Ibrutinib
Daratumumab is already approved in European Union, United States for the following indications:
- Relapsed and refractory multiple myeloma
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Multiple myeloma in patients who have received at least three prior therapies
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Woyach
Lead Sponsor