Pirtobrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia
Trial Summary
What is the purpose of this trial?
This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL).
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on certain immunosuppressive drugs or investigational agents, and there are restrictions on recent use of high-dose steroids and live vaccines.
What data supports the effectiveness of the drug combination Pirtobrutinib and Obinutuzumab for treating Chronic Lymphocytic Leukemia?
Is the combination of Pirtobrutinib and Obinutuzumab safe for treating chronic lymphocytic leukemia?
Obinutuzumab, when used alone or with chemotherapy, has shown a manageable safety profile in chronic lymphocytic leukemia patients, with common side effects including low white blood cell counts and infusion-related reactions. Careful monitoring and management strategies are recommended to handle these side effects.26789
What makes the drug combination of Pirtobrutinib and Obinutuzumab unique for treating chronic lymphocytic leukemia?
Pirtobrutinib is a noncovalent Bruton's tyrosine kinase inhibitor (BTKi) that can be effective for patients who do not respond to other BTK inhibitors, making it a promising option for those with resistant forms of chronic lymphocytic leukemia. When combined with Obinutuzumab, it offers a novel approach that may enhance treatment effectiveness, especially for patients who have limited options.310111213
Research Team
Inhye Ahn
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Adults over 18 with chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment and meet specific health guidelines. They should have no prior CLL/SLL treatments, be able to take pills, and have measurable disease. Excluded are those with other serious illnesses, recent major surgery, active infections like hepatitis B/C or HIV, bleeding disorders, significant heart issues, or pregnant/breastfeeding women.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 cycles of pirtobrutinib alone followed by 6 cycles of pirtobrutinib-obinutuzumab combination therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Retreatment
Participants with progressive CLL/SLL during follow-up will receive continuous pirtobrutinib monotherapy
Treatment Details
Interventions
- Obinutuzumab
- Pirtobrutinib
Obinutuzumab is already approved in United States, European Union for the following indications:
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inhye Ahn
Lead Sponsor
Loxo Oncology, Inc.
Industry Sponsor
Jacob Van Naarden
Loxo Oncology, Inc.
Chief Executive Officer since 2019
A.B. in Molecular Biology from Princeton University
Dr. Jennifer Low
Loxo Oncology, Inc.
Chief Medical Officer since 2014
MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology