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).
This is a Phase III global, randomised, open-label, multicentre study. The study will consist of 2 sequential parts- the Dose Optimisation and Safety Run-in part and the Phase-III part. During the dose optimisation and safety run-in part, Surovatamig will be initiated in 2 dose levels. This part will help to determine the recommended phase III dose (RP3D) of Surovatamig to be used in Phase III part. Phase III would comprise of 2 arms, Arm A where the Surovatamig dose (RP3D) will be administered as a consolidation therapy (post standard of care \[SOC\] induction therapy) and Arm B where participants will be observed. In Phase 3 participants will be randomized in a 1:1 ratio to Arm A or Arm B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Surovatamig 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.
Time frame: Up to 5 years
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).
Time frame: Until disease progression or death (up to 5 years)
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
AstraZeneca Clinical Study Information Center
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Research Site
Adelaide, Australia
NOT_YET_RECRUITINGResearch Site
Fitzroy, Australia
NOT_YET_RECRUITINGResearch Site
Heidelberg, Australia
NOT_YET_RECRUITINGResearch Site
Nedlands, Australia
RECRUITINGResearch Site
Perth, Australia
NOT_YET_RECRUITINGResearch Site
Rockingham, Australia
NOT_YET_RECRUITINGResearch Site
Calgary, Alberta, Canada
NOT_YET_RECRUITINGResearch Site
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGResearch Site
Halifax, Nova Scotia, Canada
NOT_YET_RECRUITINGResearch Site
Hamilton, Ontario, Canada
NOT_YET_RECRUITING...and 20 more locations
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.
Time frame: Up to 5 years
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.
Time frame: Until disease progression or death (up to 5 years)
Overall Survival (OS)
OS is defined as the time from first dose until death due to any cause.
Time frame: Up to 5 years
Serum concentrations of Surovatamig
To characterise the serum concentration of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Time frame: At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)
Maximum concentration observed (Cmax)
To characterise the pharmacokinetics (PK) of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Time frame: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Time to Maximum Concentration (tmax)
To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Time frame: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Trough concentration (Ctrough)
To characterise the PK of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV.
Time frame: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)
Number of participants with Anti-drug antibodies (ADA)
DOSRI- To evaluate the immunogenicity of SC surovatamig as consolidation therapy in CLL/SLL participants with uIGHV. Phase III- To determine the immunogenicity of SC surovatamig in CLL/SLL participants with uIGHV.
Time frame: At predefined intervals from the date of first dose to approximately 5 years
Phase III- PFS
PFS is defined as the time from date of randomisation until disease progression or death due to any cause , whichever comes first based on iwCLL 2018 criteria, as assessed by investigator.
Time frame: Until disease progression or death (up to 5 years)
Phase III- Number of participants with AEs and SAEs
To assess safety and tolerability of SC surovatamig compared to observation in CLL/SLL participants with uIGHV.
Time frame: Up to 5 years