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Follicular LymphomaPhase 3RAZORNCT07736950

A Study Comparing a New Drug (Surovatamig) With Standard Radiotherapy With or Without Rituximab in Adults With Limited Stage Nodal Follicular Lymphoma

A Phase 3 study testing Surovatamig, Involved Site Radiotherapy (ISRT) and Involved-Site Radiotherapy (ISRT) + Rituximab in people with Follicular Lymphoma, run by Australasian Leukaemia and Lymphoma Group.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The goal of this clinical trial is to learn if surovatamig works better than standard of care involved-site radiotherapy (ISRT) with or without rituximab to treat patients with limited-stage follicular lymphoma. It will also learn about the safety of the drug. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Surovatamig, Involved Site Radiotherapy (ISRT) and Involved-Site Radiotherapy (ISRT) + Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
12 Jan 2027to 13 Jan 2035
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients or their legally authorised representative must voluntarily sign and date an informed consent, approved by an HREC, prior to the initiation of any screening or trial specific procedures.
  • Are willing and able to comply with procedures required in this protocol.
  • Age 18 years and older at the time of signing the ICF
  • Must have histologically confirmed classical FL (previously Grade 1 to 3a FL) at the most recent representative tumour biopsy based on the local pathology report, according to the 5th edition of WHO Classification of Haematolymphoid Tumours (excluding cutaneous and duodenal FL).
  • Must have Ann Arbor Stage I or II, nodal, non-bulky disease (maximum tumour diameter ≤7cm)
  • Previously untreated disease (no prior systemic lymphoma-directed therapies)
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  • Has one or more target lesions:
  • A PET/CT scan demonstrating PET-positive lesion(s), and
  • ≥ 1 measurable nodal lesion (long axis > 1.5cm) on CT scan or MRI
  • ECOG performance status 0-2
  • Patient must have adequate haematologic function:
  • ANC ≥ 1.0 x 10^9/L
  • Haemoglobin ≥ 90 g/L
  • Platelet count ≥ 100 x 10^9/L
  • Patient must have adequate renal and liver function, unless values meeting the following criteria are related to lymphoma):
  • Serum AST or ALT ≤ 3.0 × ULN
  • Total Bilirubin ≤ 1.5 × ULN; subjects with Gilbert's syndrome may have total bilirubin levels > 1.5 x ULN, but conjugated (direct) bilirubin must be ≤ 2 x ULN
  • Estimated CrCl ≥ 30 mL/min (as calculated by Cockcroft-Gault Formula)
  • Patients of child-bearing potential must have a negative serum pregnancy test 10 to 14 days prior to randomisation and again within 24 hours prior toC1D1. The pregnancy test must be sensitive to at least 25 mIU/ml.
  • Women of childbearing potential must agree to practice at least 2 protocol-specified methods of birth control, that are effective from 28 days prior to randomisation through at least 12 months after the last dose of trial therapy. Female patients of non-childbearing potential do not need to use birth control.
  • Male patients who are sexually active with female partner(s) of childbearing potential, must agree, from 28 days prior to randomisation through 12 months after the last dose of trial therapy, to practice the protocol-specified contraception, particularly a latex or synthetic condom every time they have sexual intercourse with a partner of reproductive potential, even if they have undergone a successful vasectomy.

Who cannot join

  • Has a history of prior systemic therapy or radiotherapy for FL.
  • Has prior or current Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification), histologic transformation to DLBCL or other aggressive lymphomas.
  • Inadequately staged follicular lymphoma (unable to perform staging imaging or bone marrow trephine length totalling <20mm)
  • Known or suspected CNS involvement at screening based on clinical presentation or imaging findings.
  • Prior exposure to surovatamig or a history of severe allergic or anaphylactic reactions to any component or excipient of surovatamig
  • Has had major surgery within 14 days prior to the first dose of trial intervention (excluding biopsies) pr anticipation of the need for major surgery during trial intervention
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  • Relative contraindications for radiotherapy
  • Non-rheumatoid collagen vascular disorders involving the potential radiation field
  • Radiation field that may impact on Cardiac implantable electronic devices (CIEDs).
  • Previous radiation therapy to the same site.
  • Clinically significant cardiovascular disease, such as:
  • Myocardial infarction within ≤ 12 weeks or stroke within 6 months prior to randomisation
  • Screening 12-lead ECG showing a baseline QT interval as corrected by Frederica's formula (QTcF) > 480 msec
  • The following conditions within 3 months prior to randomisation:
  • Uncontrolled unstable angina ii. New York Heart Association (NYHA) Class III-IV congestive heart failure iii. Uncontrolled life-threatening cardiac arrhythmia iv. Other clinically significant ECG abnormalities in the opinion of the investigator
  • History or presence of clinically relevant CNS pathology which, based on Investigator assessment, may prevent, limit, or confound the protocol-specified assessments of neurotoxicity. This may include current seizure disorder requiring therapy, major cerebrovascular ischemia/haemorrhage, aphasia, severe brain injuries, severe dementia, severe Parkinson's disease, or cerebellar disease. Note: patients with history of seizure disorder must have complete CNS workup
  • History of other prior malignancies, except:
  • Malignancy treated with curative intent and with no known active disease present for ≥2 years before the first dose of trial therapy and felt to be at low risk for recurrence by treating physician.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • Localized prostate cancer, post-radical prostatectomy or with non-rising prostate-specific antigen levels < 0.1 ng/mL.
  • Current autoimmune disease requiring immunosuppressive therapy other than prednisolone <10 mg daily (or equivalent)
  • Known history of hemophagocytic lymphohistiocytosis / macrophage activation syndrome (HLH/MAS) or HLH-like syndrome.
  • Active bacterial, viral (including EBV infections), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring systemic therapy or antibiotics within 2 weeks prior to randomisation. COVID-19 infection needs to resolve to Grade ≤1 before commencing on treatment.
  • HIV infection unless:
  • Patients with an HIV infection who are on effective anti-retroviral therapy with undetectable viral load within 6 months prior to trial entry are eligible for this trial.
  • HIV RNA will be monitored during the trial as clinically indicated.
  • Active hepatitis B infection (defined as the presence of detectable HBV DNA or HBs antigen).
  • Patients who are HBcAb positive but are HBV DNA and HBsAg negative are eligible.
  • If receiving surovatamig or rituximab, patients with HBcAb positive will have 12 weekly monitoring of HBV DNA for the duration of treatment and for 12 months following last dose of either therapy. These patients will receive appropriate anti-viral prophylaxis, with entecavir or similar, according to advice from the infectious disease service.
  • Patients who are HBcAb positive and received ISRT alone do not require HBV DNA monitoring.
  • Please note that patients who have received IVIG may have false positive HBcAb results. In such patients, if HBV DNA and HBsAg are negative, prophylaxis may be omitted if felt un-necessary by the infectious disease service, but monitoring of HBV DNA levels is still required.
  • Active hepatitis C, defined by the detection of hepatitis C RNA in plasma by PCR. Patients who have received treatment for hepatitis C that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable.
  • Received a live, attenuated vaccine within 28 days prior to initiation of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg. FluMist) are live, attenuated vaccines and are not allowed. Experimental and/or non-authorized SARS-CoV-2 vaccinations are not allowed.
  • NOTE: Patients should not receive live vaccine while receiving trial intervention and for a period of at least 6 months after the last dose of surovatamig or rituximab, and until B-cell recovery within a normal range is confirmed.
  • Active TB or history of completed treatment for active TB within the past 12 months - Note: IGRA testing must be performed if active or latent TB is suspected (e.g., clinical signs and symptoms of TB, contact history, or if the subject lives in or has travelled to or lived in the WHO high TB burden countries). For subjects with positive IGRA, active pulmonary TB must be excluded with clinical evaluation and radiologic imaging. Subjects with positive IGRA and no evidence of active disease may be enrolled after treatment for latent TB infection (recommend isoniazid monotherapy for a total of 6 months) has been initiated.
  • History of clinically significant medical conditions, psychiatric conditions or any other reason that the investigator determines would:
  • Interfere with individual participation in this trial OR
  • Places the patient at an unacceptably high risk for toxicities OR
  • Would make the patient an unsuitable candidate to receive trial therapy OR
  • could interfere with evaluation of the trial intervention or interpretation of patient safety or trial results
  • Participation in another clinical trial (for a separate medical comorbidity) with an investigational product administered within the last 28 days or 5 half-lives (of that agent), whichever shorter
  • Female patient who is pregnant or breastfeeding or is considering becoming pregnant or donating eggs during the trial or for approximately 12 months after the last dose of trial therapy.
  • Male patients who are considering fathering a child or donating sperm during the trial or for approximately 12 months after the last dose of trial therapy.

About this study

Official title: An ALLG International Randomised Phase III Trial of Surovatamig Versus Involved Site Radiotherapy With or Without Rituximab in Limited Stage Nodal Follicular Lymphoma

The goal of this clinical trial is to learn if surovatamig works better than standard of care involved-site radiotherapy (ISRT) with or without rituximab to treat patients with limited-stage follicular lymphoma. It will also learn about the safety of the drug.

The main questions it aims to answer is whether surovatamig can produce deeper and more durable responses, reduce the risk of disease relapse, and improve event-free survival.

Read more

Participants will:

  1. Take surovatamig for 4 cycles. The first cycle will have a dose ramp up in 3 steps over a period of 14 days. Cycle 2-4 are for 28 days with drug administered every fortnight.

OR 2a) Undergo radiotherapy only for 3 weeks OR 2b) Radiotherapy + rituximab weekly for 6 doses (6 weeks)

Visit the clinic once every cycle, at the end of treatment, and be monitored every 3 months in year 1, every 6 months in year 2, and once a year from year 3-5 for checkups and tests.

Read the detailed description

What the study is about:

This study will evaluate whether surovatamig, a novel CD19 × CD3 bispecific T-cell engager, can improve outcomes for people with previously untreated, limited-stage nodal follicular lymphoma (FL). The trial will compare surovatamig with the current standard of care: involved-site radiotherapy (ISRT) with or without rituximab. The aim is to determine whether surovatamig can produce deeper and more durable responses, reduce the risk of disease relapse, and improve event-free survival.

Who is it for:

This study is for adults aged 18 years or older who have:

  1. Histologically confirmed classical follicular lymphoma (Grade 1-3a), Ann Arbor stage I or II nodal, non-bulky disease ( less or equal to 7 cm)
  2. PET-positive, measurable disease
  3. No prior lymphoma-directed therapy

Study details:

This is an international, Phase III randomised clinical trial. Participants will be randomised 1:1 on either Surovatamig (6 doses over 12 weeks with an additional triple step-up dosing schedule over 14 days for cycle 1) or to the standard of care treatment (Involved-Site Radiotherapy (24 Gy) with or without 6 doses of rituximab, according to each site's predefined standard). Participants will be followed up for 5 years after treatment to assess long-term outcomes.

A total of 140 participants will be enrolled across Australia, New Zealand, the United Kingdom, Ireland and Nordic countries.

What is hoped from it:

If successful, surovatamig could represent a new standard of care for patients with early-stage nodal follicular lymphoma that is highly effective, well-tolerated, non-radiation frontline option for patients with limited-stage FL.

Being tested
Surovatamig, Involved Site Radiotherapy (ISRT), Involved-Site Radiotherapy (ISRT) + Rituximab
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurovatamigDrug

    Surovatamig is supplied as a concentrate for solution for intravenous administration (2mg/mL).

  • Involved Site Radiotherapy (ISRT)Radiation

    24 Gray of ISRT

  • Involved-Site Radiotherapy (ISRT) + RituximabRadiation

    Involved-Site Radiotherapy (ISRT) at 24Gy with 6 doses of rituximab administered weekly by intravenous (IV) at 375 mg/m^2. 1 week = 1 cycle.

Study groups in NCT07736950
Study groupRoleWhat they receive
Arm A (Investigational arm): SurovatamigActive comparatorThis arm involves treatment with Surovatamig only with no radiotherapy. Treatment is in 3 phases. 1. Cycle 1 is a 14 day cycle including a triple step-up dosing: Day 1 of cycle 1: 0.09 mg, Day 4 of cycle 1: 0.27 mg, Day 8 of cycle 1: 1.0 mg. 2. Cycle 2-4 are 28 day cycles with a dose administered every 2 weeks: Cycles 2-4 (28-day cycle): Surovatamig treatment doses administered on days 1 and 15 of each cycle at 7.2mg. 3. At the end of cycle 4, patients will enter the post-treatment period.
Receives: Drug: Surovatamig
Arm B1: Involved-Site Radiotherapy (ISRT) 24GyActive comparatorThis arm is the standard of care (SOC): Involved-Site Radiotherapy (ISRT) at 24Gy and involves radiotherapy for 3 weeks.
Receives: Radiation: Involved Site Radiotherapy (ISRT)
Arm B2: Involved-Site Radiotherapy (ISRT) 24Gy + rituximab x 6 cyclesActive comparatorThis arm is another standard of care (SOC): Involved-Site Radiotherapy (ISRT) at 24Gy with 6 doses of rituximab administered weekly by intravenous (IV) at 375 mg/m^2. 1 week = 1 cycle.
Receives: Radiation: Involved-Site Radiotherapy (ISRT) + Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

    Defined as death from any cause, failure to achieve complete response (CR) at End-of-Treatment ((EoT); defined as 18 weeks from start of treatment), initiation of new anti-lymphoma treatment (including new RT) or disease progression (based on Lugano 2014 Response Criteria), whichever comes first

    Measured: Time from date of randomisation until disease progression until end of 5 year follow up.

  2. Event Free Survival

    As determined by the Lugano 2014 Response Criteria and audit of medical records

    Measured: Time from date of randomisation to death from any cause, initiation of new anti-lymphoma treatment or disease progression until end of 10 year follow up. Assessment will be performed at end of treatment, every 3 months in year 1, every 6 months in year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start12 Jan 2027 (estimated)
  3. Primary completion13 Jan 2035 (estimated)
  4. Study completion13 Jan 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07736950
Sponsor's protocol ID
ALLG NHL45
Other IDs
ACTRN12626000311358
Acronym
RAZOR
Status last verified
Sep 2026
First submitted
27 Jul 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Surovatamig, Involved Site Radiotherapy (ISRT) and Involved-Site Radiotherapy (ISRT) + Rituximab in people with Follicular Lymphoma, run by Australasian Leukaemia and Lymphoma Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (time frame: Time from date of randomisation until disease progression until end of 5 year follow up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07736950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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