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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating BGB-16673, an oral drug, in adults with various types of B-cell malignancies such as marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrm macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. This study includes Phase 1 dose finding and safety expansion, followed by Phase 2 expansion cohorts to determine recommended doses and further assess safety and efficacy. The study is divided into several parts, starting with Phase 1 dose escalation to find safe dosage levels, including monotherapy dose escalation and safety expansion in selected doses. Phase 2 involves expansion cohorts where participants receive the recommended doses identified in Phase 1 for further safety and efficacy evaluation. Some cohorts include participants who have not received prior BTK inhibitors, and Japanese participants are also enrolled to assess safety. Treatments are orally administered. Participants will undergo regular assessments including monitoring for adverse events, disease response, and drug concentration levels in the blood at various time points. Researchers will measure outcomes such as overall response rate and progression-free survival over approximately three years. Safety and tolerability will be closely tracked, and quality of life questionnaires will be completed at scheduled intervals. Participation may last several years, including follow-up periods to monitor long-term effects.

Age: 18Years +All GendersPhase 1Phase 2
114 locations
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Actively Recruiting

Researchers are evaluating nemtabrutinib compared with investigators choice of ibrutinib or acalabrutinib in adults with untreated chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study aims to assess whether nemtabrutinib is not worse than these comparators in terms of objective response rate and whether it can provide longer progression-free survival. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will receive either nemtabrutinib, ibrutinib, or acalabrutinib orally at specified doses until their disease progresses, unacceptable side effects occur, or other discontinuation criteria are met. The trial uses a parallel-group design where participants are randomly assigned to one of the treatment groups, and no masking is involved. Both treatment arms continue until progression or intolerance. During the study, participants will be monitored regularly up to about 33 months for response rate and up to about 104 months for progression-free survival and overall survival. Assessments include clinical evaluations, safety monitoring for adverse events, and duration of response measurements. The study tracks treatment tolerability, discontinuations due to adverse events, and overall outcomes to better understand the therapies effects in this patient population.

Age: 18Years +All GendersPhase 3
201 locations
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Actively Recruiting

This research aims to evaluate the long-term safety of pirtobrutinib in people who have previously been treated for chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. It offers continued access to the study drug or follow-up for participants who completed a prior related study LOXO-BTK-20020. The study is designed to observe and monitor safety outcomes over an extended period. Participants receive either pirtobrutinib or idelalisib orally as part of the study treatments. These medications are taken every four weeks. The study is expected to last about five years, allowing researchers to collect long-term safety data on these treatments in a parallel group setup. Throughout the study, participants will have regular visits to monitor their health and any treatment-related effects. Researchers will track the percentage of participants experiencing serious treatment-emergent adverse events. They will also observe overall survival from the original study enrollment. Safety monitoring will continue up to 30 days after the last dose or until new anticancer therapy begins, ensuring careful follow-up for each participant.

Age: 18Years +All GendersPhase 4
49 locations
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Actively Recruiting

Researchers are evaluating the safety and efficacy of nemtabrutinib in adults with various blood cancers, including chronic lymphocytic leukemia CLL, small lymphocytic lymphoma SLL, Richters transformation, marginal zone lymphoma MZL, mantle cell lymphoma MCL, follicular lymphoma FL, and Waldenstrms macroglobulinemia WM. The study is a phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC, designed to explore how well nemtabrutinib works and its safety profile in these hematologic malignancies. The study has two parts Part 1 focuses on dose escalation and confirmation to identify the recommended phase 2 dose, while Part 2 involves cohort expansion across eight disease-specific groups. Participants take nemtabrutinib tablets orally once daily until their disease progresses or they stop treatment. This approach allows researchers to assess responses across different types of blood cancer and treatment histories. Participants will be involved in regular assessments including monitoring for adverse events, evaluating response rates using established criteria for each disease type, and biomarker analysis from biopsies or bone marrow samples. Safety and response will be tracked over several months, up to about five to six years. The study also monitors drug levels in the body and collects detailed data on how participants tolerate the treatment during this period.

Age: 18Years +All GendersPhase 2
120 locations