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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (9 UK sites)
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
Hampshire SO16 6YD, United Kingdom
Research Site
Leeds LS9 7TF, United Kingdom
Research Site
London NW1 2BU, United Kingdom
Research Site
London SE5 9RS, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Nottingham NG5 1PB, United Kingdom
Research Site
Oxford OX3 7LE, United Kingdom
Research Site
Sutton SM2 5PT, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
