Phase III Study of Surovatamig Injection as Consolidation Treatment Compared to Observation in Adults with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma Having Unmutated IGHV

What this Trial Is About

Researchers are evaluating the safety and therapeutic benefit of subcutaneous Surovatamig as a consolidation therapy for patients with Chronic Lymphocytic Leukemia CLL or Small Lymphocytic Lymphoma SLL who have an unmutated Immunoglobulin Heavy Chain Variable IGHV gene. This Phase III, randomized, open-label study aims to compare Surovatamig treatment versus observation after initial standard therapy in these patients. The study includes a dose optimization and safety run-in phase followed by the main Phase III treatment and observation phase. The study begins with a dose optimization and safety run-in part where two different doses of Surovatamig are tested subcutaneously to determine the recommended dose for Phase III. In Phase III, participants are randomly assigned to one of two groups one receiving the recommended dose of Surovatamig as consolidation therapy for six 28-day cycles, and the other undergoing observation for 24 weeks without additional treatment. The drug is delivered by subcutaneous injections. Participants will be closely monitored throughout the study for adverse events, disease progression, and response to treatment. Assessments include safety evaluations, measuring progression-free survival, overall survival, and various pharmacokinetic and immunogenicity parameters over up to five years. The study involves regular visits for treatment administration or observation and long-term follow-up to evaluate outcomes and safety.

Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)