- Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV) — Recruiting • Phase III • Oncology • NCT07509151.
- What is being tested: Surovatamig (a subcutaneous monoclonal antibody) administered as consolidation therapy following initial treatment in patients with CLL/SLL, focusing on therapeutic efficacy and safety profile in this high-risk population.
- Patient eligibility overview: Participants with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma characterised by unmutated IGHV status, which represents a biologically aggressive disease subtype with poorer prognosis than mutated counterparts.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).
- : * Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV. * Treatment received and response at the end of 1L (first-line) finite therapy. * Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion. * ECOG performance status of 0 to 2. * Adequate haematologic, liver, renal and cardiac function. * Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception. * Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms).
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.