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

NCT07509151 · AstraZeneca
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Official title
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)
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Study design
Enrollment target: 420 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2026-05-05
Estimated completion: 2032-04-05
Last updated: 2026-09-08
Interventions
Drug: Surovatamig
Primary outcomes
  • DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs) (Up to 5 years)
  • Phase III- Progression Free Survival (PFS) (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 (Up to 5 years)
Sponsor
AstraZeneca · industry
With: Parexel
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (44)
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La Jolla, California, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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Basking Ridge, New Jersey, United States
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Rochester, New York, United States
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Cleveland, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Adelaide, Australia
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Fitzroy, Australia
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Heidelberg, Australia
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Nedlands, Australia
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Perth, Australia
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Rockingham, Australia
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Adapazarı, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Mezitli, Turkey (Türkiye)
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Edinburgh, United Kingdom
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Hampshire, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Nottingham, United Kingdom
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Oxford, United Kingdom
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Sutton, United Kingdom