Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
SOUNDTRACK-C1
A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (SOUNDTRACK-C1)
1 other identifier
interventional
420
4 countries
30
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2026
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2026
CompletedFirst Posted
Study publicly available on registry
April 3, 2026
CompletedStudy Start
First participant enrolled
May 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 5, 2032
July 9, 2026
July 1, 2026
5.3 years
March 27, 2026
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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).
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.
Up to 5 years
Secondary Outcomes (12)
Objective Response Rate (ORR)
Up to 5 years
Complete Response rate (CR rate)
Up to 5 years
Duration of response (DoR)
Up to 5 years
DOSRI- PFS
Until disease progression or death (up to 5 years)
Overall Survival (OS)
Up to 5 years
- +7 more secondary outcomes
Study Arms (4)
Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1
EXPERIMENTALParticipants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).
DOSRI-Surovatamig Dose 2
EXPERIMENTALParticipants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).
Phase III-Arm A: Surovatamig SC
EXPERIMENTALParticipants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).
Phase III-Arm B: Observation
NO INTERVENTIONParticipants will undergo observation for 24 weeks.
Interventions
Surovatamig will be administered as a subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- Participants with:
- Active or uncontrolled infection (including Epstein-Barr virus-EBV) requiring systemic therapy.
- Participants with known history of Heamophagocytic lymphohistiocytosis (HLH).
- Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
- Major cardiac abnormalities.
- Prior CLL/SLL-specific therapies.
- Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition or prior allogeneic stem cell or solid organ transplant.
- Major surgical procedure.
- Known hypersensitivity to surovatamig or any of the excipients of the product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (30)
Research Site
Adelaide, 5000, Australia
Research Site
Fitzroy, 3065, Australia
Research Site
Heidelberg, 3084, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Perth, 6847, Australia
Research Site
Rockingham, 6168, Australia
Research Site
Calgary, Alberta, T2N 5G2, Canada
Research Site
Vancouver, British Columbia, V5Z 4E6, Canada
Research Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Toronto, Ontario, M5G 2L7, Canada
Research Site
Montreal, Quebec, H2L 4M1, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Québec, Quebec, G1J 1Z4, Canada
Research Site
Adapazarı, 54100, Turkey (Türkiye)
Research Site
Antalya, 07025, Turkey (Türkiye)
Research Site
Istanbul, 34098, Turkey (Türkiye)
Research Site
Istanbul, 34517, Turkey (Türkiye)
Research Site
Istanbul, 34899, Turkey (Türkiye)
Research Site
Kocaeli, 41380, Turkey (Türkiye)
Research Site
Mezitli, 33200, Turkey (Türkiye)
Research Site
Edinburgh, EH4 2XU, United Kingdom
Research Site
Hampshire, SO16 6YD, United Kingdom
Research Site
Leeds, LS9 7TF, United Kingdom
Research Site
London, NW1 2BU, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Research Site
Nottingham, NG5 1PB, United Kingdom
Research Site
Oxford, OX3 7LE, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2026
First Posted
April 3, 2026
Study Start
May 5, 2026
Primary Completion (Estimated)
August 29, 2031
Study Completion (Estimated)
April 5, 2032
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.