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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)

RecruitingPhase 3

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)

Who can join

Ages 18 to 18 · All sexes

Full 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.

About the study

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 is being tested

Sponsor: AstraZeneca · Participants: 420 · Started: May 5, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07509151

Locations in the U.S.

CaliforniaResearch Site, La Jolla (Not yet recruiting)
ColoradoResearch Site, Denver (Not yet recruiting)
ConnecticutResearch Site, New Haven (Not yet recruiting)
IllinoisResearch Site, Chicago (Not yet recruiting)
KansasResearch Site, Kansas City (Not yet recruiting)
KentuckyResearch Site, Louisville (Not yet recruiting)
MarylandResearch Site, Bethesda (Not yet recruiting)
MassachusettsResearch Site, Boston (Not yet recruiting)
MinnesotaResearch Site, Rochester (Not yet recruiting)
New JerseyResearch Site, Basking Ridge (Not yet recruiting)
New YorkResearch Site, Rochester (Not yet recruiting)
OhioResearch Site, Cleveland (Not yet recruiting)
PennsylvaniaResearch Site, Pittsburgh (Not yet recruiting)
TexasResearch Site, Houston (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.