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Follicular Lymphoma Stage IIPhase 2TOP-FLORNCT05788081

Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab.

A Phase 2 study testing golcadomide, Nivolumab 10 MG/ML and Rituximab in people with Follicular Lymphoma Stage II and Follicular Lymphoma Stage III, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

First line treatment with combination rituximab and golcadomide with, or without nivolumab, in patients in previously untreated Follicular Lymphoma Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
golcadomide, Nivolumab 10 MG/ML and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesAustralia
Study dates
31 Aug 2023to 1 Jun 2029
Phase
Phase 2
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

  • Age 18+ years.
  • Histologically proven CD20 positive Follicular non Hodgkin lymphoma (FL) grades 1-3A (i.e. classical follicular lymphoma according to the current World Health Organization classification).3
  • No previous chemotherapy, or other investigational drug for this indication apart from focal radiotherapy.
  • Stage II-IV disease (Ann Arbor criteria).
  • Eastern Collaborative Oncology Group (ECOG) performance status 0 to 1 unless attributable to lymphoma, in which case patients of performance status 2 are also eligible.
  • Measurable FDG avid disease on baseline PET/CT scan.
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  • Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to:
  • Any nodal or extranodal tumour mass >7cm AND/OR multiple extranodal disease sites b. Involvement of at least 3 sites each with diameter >3cm c. Symptomatic splenic enlargement d. Organ involvement/compression e. Ascites or pleural effusion f. Lactate Dehydrogenase (LDH) elevated g. Presence of systemic symptoms h. Disease progression in preceding 3 months i. Evidence of marrow infiltration with marrow compromise. (e.g., Hb, WCC or plt count below lower limit of institutional normal range).
  • Adequate bone marrow function including:
  • Haemoglobin >8.0 g/dL
  • White cell count (WCC) ≥2000/μL
  • Neutrophils >1.5 x 109/L
  • Platelets >75 x 109/L at the time of study entry, unless attributed to bone marrow infiltration by lymphoma.
  • Adequate renal function with serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 60mL/min (using Cockcroft-Gault formula, 24hr urine collection or eGFR).
  • Female CrCl = (140 - age in years) x weight (kg) x 0.85 72 x serum creatinine (mg/dL)
  • Male CrCl = (140 - age in years) x weight (kg) x 1.00 72 x serum creatinine (mg/dL) j) Adequate hepatic function with AST/ALT ≤3x ULN and total bilirubin ≤1.5 x ULN (except subjects with Gilbert syndrome, who can have a total bilirubin ≤3 mg/dL or ≤51.3 μmol/L).
  • Adequate left ventricular ejection fraction of >45% as demonstrated on a Gated Cardiac Blood Pool Scan or echocardiogram.
  • Life expectancy > 3 months. m) Patients of childbearing potential willing to adhere to the following contraceptive precautions.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.
  • Females must not be breastfeeding.
  • FCBP must use appropriate method(s) of contraception to avoid pregnancy for 23 weeks (30 days plus five half-lives of nivolumab) and 28 days for golcadomide post-treatment completion.
  • Men who are sexually active with FCBP must use any contraceptive method with a failure rate of less than 1% per year. They must agree to adhere to contraception for a period of 90 days from the last day golcadomide and refrain from donating sperm.
  • Azoospermic males and FCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.
  • Written, informed consent.

Who cannot join

  • Follicular large B-cell Lymphoma (Grade 3B) transformed follicular lymphoma, other indolent lymphomas.
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Central nervous system, meningeal involvement or spinal cord compression by lymphoma.
  • Patients with active, known or suspected autoimmune disease. Patients with well controlled type I diabetes mellitus, coeliac disease, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, vitiligo or psoriasis not requiring systemic treatment, or other conditions not expected to recur in the absence of an external trigger are permitted to enrol.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement therapy are permitted in the absence of active autoimmune disease.
  • Past history of interstitial lung disease.
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  • Prior organ transplantation or allogeneic bone marrow transplantation.
  • Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Uncontrolled or severe cardiovascular disease (NYHA class III or IV heart failure; myocardial infarction within the last 6 months of study entry); unstable angina; unstable cardiac arrhythmias; clinically significant pericardial disease.
  • Any other serious active disease.
  • Any positive test result for hepatitis B or hepatitis C virus during screening indicating acute or chronic infection. Latent hepatitis B with undetectable viral load by PCR is allowable provided appropriate anti-viral prophylaxis is given as per institutional guidelines.
  • Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Any history of severe hypersensitivity reactions to other monoclonal antibodies.
  • A history of allergy or intolerance (unacceptable AEs) to study drug components or Polysorbate-80-containing infusions.
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Grampians Health

    Ballarat, Victoria

  • Eastern Health

    Box Hill, Victoria, 3128

  • University Hospital Geelong, Barwon Health

    Geelong, Victoria

  • Austin Health

    Heidelberg, Victoria, 3078

  • Fiona Stanley Hospital

    Perth, Western Australia

Other trials in Australia

About this study

Official title: Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab: An Umbrella Bayesian Optimal Phase II Study.

First line treatment with combination rituximab and golcadomide with, or without nivolumab, in patients in previously untreated Follicular Lymphoma

Read the detailed description

This study will involve participants with a condition called Follicular Non Hodgkin Lymphoma (Follicular Lymphoma).

The main purpose of this study is to see if it is safe to give an induction schedule of the drug golcadomide, in combination with Rituximab +/- Nivolumab, and to see how effective this combination is in patients who have had no previous drug treatment for their lymphoma. In particular, we will be monitoring for any specific side effects which may be increased by adding golcadomide to Rituximab treatment +/- Nivolumab for 8 cycles (28 days per cycle), with up to 2 years of maintenance treatment of rituximab in eligible patients following induction.

Participants will be reviewed at baseline and prior to each cycle of treatment for toxicity, scans will be performed at baseline, after 2 and 5 cycles of induction treatment, and every 8 weeks during maintenance phase. Following completion of treatment, participants will be followed up for a total of 3 years (every 6 months). In participants with relapsed disease, these will be followed for survival every 3 months.

Being tested
golcadomide, Nivolumab 10 MG/ML, 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.

  • golcadomideDrug

    Also called BMS-986369, CC-99282

    BMS-986369 is an orally administered Cereblon-modulating compound

  • Nivolumab 10 MG/MLDrug

    Also called Opdivo

    Nivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1.

  • RituximabDrug

    Also called Mabthera

    Rituximab is a chimeric anti-CD20 antibody containing human IgG lambda and kappa constant regions with murine variable regions

Study groups in NCT05788081
Study groupRoleWhat they receive
Arm A- Golcadomide + RituximabExperimentalRituximab 375mg/m2 IV infusion Q4W + golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction
Receives: Drug: golcadomide; Drug: Rituximab
Arm B- Nivolumab + golcadomide + RituximabExperimentalNivolumab 480mg IV infusion Q4W, Rituximab 375mg/m2 IV infusion Q4W and golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction
Receives: Drug: golcadomide; Drug: Nivolumab 10 MG/ML; Drug: Rituximab

What is being measured

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

  1. Proportion of patients who achieve a complete metabolic response in the absence of prohibitive toxicity with induction rituximab, golcadomide with or without nivolumab comprising 8 cycles of therapy with each cycle delivered every 4 weeks.

    Metabolic response as assessed by PET/CT and defined by Lugano criteria; toxicities as defined by CTCAE v5

    Measured: Consent to 8 weeks after last induction treatment (maximum 44 weeks)

Secondary outcomes (4)

  1. To assess overall toxicity

    As determined by rate of toxicity grade 3 or higher per CTCAE V5

    Measured: Day 1 to 30 days after the end of maintenance phase (up to maximum 32 months)

  2. To assess time to treatment failure

    Treatment response assessed by PET/CT according to the Lugano classification for Response Criteria for Non-Hodgkin Lymphoma

    Measured: Day 1 end of follow up period (up to a maximum of 5 years)

  3. Progression free survival

    Quantification of progression free survival

    Measured: Day 1 end of follow up period (up to a maximum of 5 years)

  4. Overall survival

    Quantification of OS

    Measured: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Timeline

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

  1. First posted28 Mar 2023
  2. Study start31 Aug 2023
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jun 2029 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study Design Open label multicentre umbrella Bayesian Optimal Phase II study
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05788081
Sponsor's protocol ID
IM048-1036
Acronym
TOP-FLOR
Status last verified
Oct 2026
First submitted
15 Mar 2023
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing golcadomide, Nivolumab 10 MG/ML and Rituximab in people with Follicular Lymphoma Stage II and Follicular Lymphoma Stage III, run by Olivia Newton-John Cancer Research Institute at 5 sites in Australia.

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 24 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Proportion of patients who achieve a complete metabolic response in the absence of prohibitive toxicity with induction rituximab, golcadomide with or without nivolumab comprising 8 cycles of therapy with each cycle delivered every 4 weeks. (time frame: Consent to 8 weeks after last induction treatment (maximum 44 weeks)). 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 NCT05788081.

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 16 Oct 2026.

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