What this study is
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).
What's being tested
- Surovatamig
Intervention · DRUG
Surovatamig will be administered as a subcutaneous injection.
Study details
- 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)
- Sponsor
- AstraZeneca
- Conditions
- Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV
- Enrolling
- 420 people
- Starts
- 2026-05-05
- Est. completion
- 2032-04-05
- Design
- Open-label, randomized, sequential groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (44)
41 openResearch Site
La Jolla, California, United States
Not yet recruitingResearch Site
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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30 sites outside the US
Research Site
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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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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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
Not yet recruitingResearch Site
London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Nottingham, United Kingdom
RecruitingResearch Site
Oxford, United Kingdom
RecruitingResearch Site
Sutton, United Kingdom
RecruitingResearch Site
Vancouver, British Columbia, Canada
SuspendedResearch Site
Montreal, Quebec, Canada
SuspendedResearch Site
Québec, Quebec, Canada
Suspended
Study team
Sponsor
AstraZeneca
Study ID D7409C00001
CONTACT
AstraZeneca Clinical Study Information Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.