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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT07509151

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Surovatamig (drug)
How long the study runs
Study runs about 71 months (dates as stated)
About the drug or intervention
Surovatamig — drug: Surovatamig will be administered as a subcutaneous injection.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 18 Years
Who
All
Number of participants
420
Started
2026-05-05
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma with unmutated ighv
  • • Phase3 - 420 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 18 Years
  • • Diagnosed with chronic lymphocytic leukaemia or small lymphocytic lymphoma with unmutated ighv

Where?

  • • Edinburgh - Research Site
  • • Hampshire - Research Site
  • • Leeds - Research Site
  • • London - Research Site
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 18 Years
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Treatment history

Treatments you must have had:

  • ✓ measurable disease (nodal or extranodal) with at least one measurable target lesion

What the study is looking for

  • ✓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 cancer that can be measured on scans (nodal or extranodal) with...
  • ✓Fit enough for normal activity (ECOG 0) to 2.
  • ✓Adequate haematologic, liver, kidney and heart function.

Who cannot take part

  • ✗Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's...
  • ✗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 cancer.
  • ✗Participants with:
See the full 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.

Where Is This Study? (9 UK sites)

Research Site

Edinburgh EH4 2XU, United Kingdom

Recruiting

Research Site

Hampshire SO16 6YD, United Kingdom

Recruiting

Research Site

Leeds LS9 7TF, United Kingdom

NOT_YET_RECRUITING

Research Site

London NW1 2BU, United Kingdom

Recruiting

Research Site

London SE5 9RS, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Nottingham NG5 1PB, United Kingdom

Recruiting

Research Site

Oxford OX3 7LE, United Kingdom

Recruiting

Research Site

Sutton SM2 5PT, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10