Research Paper on As Frontline Therapy for Chronic Lymphocytic Leukemia, Ibrutinib and Obinutuzumab is linked to sustained remissions after stopping ibrutinib, as well as a lower rate of infusion-related reactions: A Phase 1b/2 single-arm, open-label clinical trial NCT0231576

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Title: As Frontline Therapy for Chronic Lymphocytic Leukemia, Ibrutinib and Obinutuzumab is linked to sustained remissions after stopping ibrutinib, as well as a lower rate of infusion-related reactions: A Phase 1b/2 single-arm, open-label clinical trial NCT0231576

Abstract: Therapies based on ibrutinib are pricy and necessitate ongoing administration. We predicted that using anti-CD20 monoclonal antibodies along with BTK inhibition would result in profound remissions that would permit discontinuation. We enrolled 32 CLL patients who had never received therapy to receive ibrutinib plus obinutuzumab, then ibrutinib alone. Patients who had a sustained complete response could stop taking ibrutinib after 36 months (CR). After stopping ibrutinib, we assessed the safety, effectiveness, and outcomes of the treatment. The overall response rate was 100%, 28% of patients achieved a complete response, and 12.5% had minimally detectable disease in the bone marrow. 91% of patients are still in remission with 100% overall survival at a three-year median follow-up. Five patients who were in sustained CR stopped taking ibrutinib but did not advance. Only two of the eight non-CR patients who discontinued for other causes progressed. The IRR rate was lower, and the treatment was safe. After stopping ibrutinib, all patients responded to treatment with longer times to progression. Our findings lend support to the analysis of ibrutinib discontinuation tactics in larger clinical trials (ClinicalTrials.gov Identifier: https://ClinicalTrials.gov/ct2/show/NCT02315768).

Paper Quality: SCOPUS / Web of Science Level Research Paper

Subject: Medicine

Sub Category: Hematology

Writer Experience: 20+ Years

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