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.
Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL).
Evidence of active or history of Central Nervous System (CNS) involvement by CLL/SLL.
History of or ongoing confirmed progressive multifocal leukoencephalopathy.
Participants who have any concurrent or history of malignancy.
Sequential
Surovatamig
DrugSurovatamig will be administered as a subcutaneous injection.
DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
Phase III- Progression Free Survival (PFS)
PFS is defined as the time from date of randomisation until disease progression or death due to any cause, whichever occur first based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria, as assessed by independent review committee (IRC).
DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs
To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving either a partial response (PR) or complete response (CR)/complete response with incomplete haematological recovery (CRi) based on response criteria iwCLL 2018, as assessed by IRC or investigator at any point during therapy/observation.
Complete Response rate (CR rate)
CR rate is defined as the proportion of participants achieving a CR or CRi as best response based on response criteria for iwCLL 2018.
Duration of response (DoR)
The DoR is defined as the time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018.
DOSRI- PFS
PFS for Safety Run-in phase is defined as the time from first dose until the date of documented progression or death due to any cause whichever comes first, based on iwCLL 2018 criteria.
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AstraZeneca
Lead sponsor
Parexel
Collaborator
