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RecruitingLast updated: 31 July 2026

SOUNDTRACK-C1: Evaluating whether consolidation treatment with surovatamig can help keep chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) under control in people who have completed first-line treatmentA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 18

Trial acronym

SOUNDTRACK-C1

Clinical summary

Summary

This study is looking at whether a medicine called surovatamig, given as an injection under the skin, can help people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) keep the cancer under control after they have completed their standard treatment.

The aim of the study is to find out whether surovatamig can help prevent CLL or SLL from returning or worsening, while also assessing its safety and side effects. 

Who can take part?
You may be eligible for this study if:

  • you have CLL or SLL
  • your cancer has a genetic feature called unmutated IGHV (uIGHV)
  • you have completed first-line treatment and your cancer responded to treatment

The study has two parts.

Dose-finding and safety phase
A small number of participants will receive different doses of surovatamig to help determine the most appropriate dose to use in the main study. Researchers will also monitor safety and side effects.

Main Phase III study
Participants who have completed their standard treatment for CLL or SLL will be randomly assigned (by chance) to one of two groups:

  • Surovatamig group: receives surovatamig as consolidation treatment to help keep the cancer under control.
  • Observation group: receives no additional treatment but is monitored closely.

 

Conditions

This trial is treating people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific 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)

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