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Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab. | Clinical Trials | Clareo Health

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

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

NCT05788081•Olivia Newton-John Cancer Research Institute

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18+ years.
•2. 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
•3. No previous chemotherapy, or other investigational drug for this indication apart from focal radiotherapy.
•4. Stage II-IV disease (Ann Arbor criteria).
•5. 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.
•6. Measurable FDG avid disease on baseline PET/CT scan.
•7. Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to:
•a. 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).
•h) Adequate bone marrow function including:
•1. Haemoglobin \>8.0 g/dL
+14 more criteria

Exclusion Criteria

•1. Follicular large B-cell Lymphoma (Grade 3B) transformed follicular lymphoma, other indolent lymphomas.
•2. 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.
•3. Central nervous system, meningeal involvement or spinal cord compression by lymphoma.
•4. 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.
•5. 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.
•6. Past history of interstitial lung disease.
•7. Prior organ transplantation or allogeneic bone marrow transplantation.
•8. 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.
•9. 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.
•10. Any other serious active disease.
+5 more criteria

Locations (5)

Grampians Health

Ballarat, Victoria, Australia

Eastern Health

Box Hill, Victoria, Australia

University Hospital Geelong, Barwon Health

Geelong, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Fiona Stanley Hospital

Perth, Western Australia, Australia

Key Dates

Start Date

August 31, 2023

Primary Completion Date

January 1, 2027

Completion Date

June 1, 2027

Last Updated

August 20, 2025

Enrollment

ESTIMATED participants

Conditions

Follicular Lymphoma Stage IIFollicular Lymphoma Stage IIIFollicular Lymphoma Stage IV

Interventions

golcadomide

DRUG

Nivolumab 10 MG/ML

DRUG

Rituximab

DRUG