Study Comparing Golcadomide and Rituximab with Other Treatments for Patients with Relapsed or Refractory Follicular Lymphoma

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What is this study about?

This clinical trial is investigating the efficacy and safety of golcadomide in combination with rituximab compared to investigator’s choice of treatment in people with relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer that affects white blood cells called B lymphocytes. “Relapsed/refractory” means the cancer has returned after treatment or did not respond adequately to previous treatments.

The purpose of this study is to evaluate whether the combination of golcadomide and rituximab is more effective than other treatment options chosen by investigators for patients whose follicular lymphoma has not responded well to previous therapies. During the study, participants will receive either the combination treatment or another treatment selected by their doctor.

The study will track various outcomes including how long participants live without their disease getting worse, overall survival time, how well the cancer responds to treatment, and how the treatment affects quality of life. Participants must be over 18 years of age and meet specific health criteria to join the study.

1 Study Assignment

You will be randomly assigned to receive either Golcadomide in combination with Rituximab (Golca + R) or an Investigator’s Choice treatment for your relapsed/refractory follicular lymphoma (a type of blood cancer that affects the lymphatic system and has returned or not responded to previous treatment).

2 Treatment Phase

If assigned to the Golcadomide plus Rituximab group: You will take Golcadomide orally in capsule form, and receive Rituximab, which is given through an intravenous (IV) infusion (directly into your vein).

If assigned to the Investigator’s Choice group: You may receive one of several standard treatments which could include combinations of medications such as bendamustine hydrochloride, cyclophosphamide, lenalidomide, rituximab, betamethasone sodium phosphate, prednisone, doxorubicin hydrochloride, vincristine sulfate, or pegfilgrastim. The specific regimen will be determined by your doctor.

3 Regular Assessments

Throughout the study, you will have regular visits to evaluate how your cancer is responding to treatment. These assessments will follow the Lugano 2014 classification guidelines, which are standard criteria for evaluating lymphoma response.

Assessments will include blood tests, imaging studies, and physical examinations to monitor your cancer and any side effects from treatment.

4 Quality of Life Evaluations

You will complete questionnaires about how you feel and how the treatment is affecting your daily life. These help researchers understand the impact of treatment beyond just the medical effects.

5 Monitoring for Disease Progression

Your cancer will be regularly monitored to check if it is responding to treatment, staying stable, or progressing (getting worse).

If your disease progresses, this will be documented as part of the study’s primary measurement (progression-free survival).

6 Follow-up Period

After completing treatment, you will enter a follow-up period where your health will continue to be monitored.

The study will track how long you live overall, whether you need to start new treatments, and the long-term outcomes of your cancer response.

7 Study Completion

The study is expected to run until July 14, 2025, with final data collection for the primary outcome measure.

The entire study, including long-term follow-up, is anticipated to continue until November 6, 2027.

Who Can Join the Study?

  • Must be over 18 years old
  • Must have Relapsed/Refractory Follicular Lymphoma (a type of blood cancer that has returned after treatment or did not respond to previous treatments)
  • Must meet specific disease characteristics required by the study
  • Must have acceptable laboratory values (blood test results) as defined by the study
  • Must meet reproductive capacity requirements (this may include using effective birth control methods during the study if able to have children)

Who Cannot Join the Study?

  • You have previously received more than two treatments for your follicular lymphoma.
  • You have undergone treatment with obinutuzumab (a type of cancer medication) less than 12 months ago.
  • You have a type of cancer called transformed follicular lymphoma.
  • You have previously received certain treatments including CAR-T cell therapy (a treatment that uses your own immune cells) or golvatinib (the study medication).
  • You have had a stem cell transplant (a procedure to replace damaged bone marrow with healthy cells) within the last 100 days.
  • You have active central nervous system (brain and spinal cord) lymphoma.
  • You have other significant medical conditions that could interfere with the study, such as serious heart problems, infections, or other cancers.
  • You are pregnant or breastfeeding.
  • You cannot use effective contraception during the study period if you are able to have children.
  • You have laboratory test results that show significant abnormalities in your blood counts, liver function, or kidney function.
  • You are currently participating in another clinical trial with an experimental treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
University Hospital Jena KöR Jena Germany
Centre Hospitalier Universitaire De Lille Lille France
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Nantes Nantes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Lsiqk Gbyiocr Hjsywyco Ox Aprmnc Athens Greece
Uvsdyhfhua Gyqwuuu Henrpbyp Op Iqpfbbbq Ioannina Greece
Evuzlnqjxomrlfpvypjfraiijm Hpsvcnrj oi Asyklu Athens Greece
Ijyyaylg Rtogbumry Pmd Lh Shevef Dkm Tojvhe Dusd Arwckma Idqz Shcjxa Meldola Italy
Ajuhitahw Uax Amsterdam The Netherlands
Ucgandyajyaj Mowlbwl Cryeknh Ushorsg Utrecht The Netherlands
Uylbtiebfeatwiwirgapq Dgmzkqvkvxn Abc Duesseldorf Germany
Kqlyikhq Cmbphfcp grmdm Chemnitz Germany
Hogvhtyv Ueyydxzmfn Clpgmhs Hvvtnxiv Helsinki Finland
Hlxexhdz Ugejqlkskrshn Fyuxovubz Jgnpnrf Dxqj Madrid Spain
Cvjgab Htwaebricnv Urbcrwyrpvkgv Dm Mebrhutcjtf Montpellier France
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Uqmcxpldet Gjtlklu Hvfmrxje Oo Acpnkgtfuozgbb Alexandroupoli Greece
Kvsimnnn dzs Urltvphlshsr Mfqqtlal Afi Munich Germany
Axsjlvz Ukzfw Stwwwdtqw Lizatk Dx Bzltxmv Bologna Italy
Uzrzfmoubnzu Mbmvhjf Clwjnkp Glltzxprd Groningen The Netherlands
Cckhbj Hxodvnutgam Lpgd Ssq Pierre Benite France
Hfcqhcnl Uvqxonlncdtnv Mntmzns Dy Vgxajgxqec Santander Spain
Gkuysn Nvgurbbfjk Tgozqzhbiougt Glhbmb Pmwugfogzpmv Thessaloniki Greece
Snumazts Plswkmvzl Sdx z osru Gdynia Poland
Ojfg Uxhgfxvqnb Hccwxrkx Oulu Finland
Hfolcxdq Ukjqpezmbxmaw Vxsldd Dn Ltv Nmwknc Granada Spain
Ahupivn Orjxvxuyoik Uidhalgtkipeq Polcke Pisa Italy
Pwai Tltfj Hwyhklao Uvyworsuxbkx Sabadell Spain
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Aozpdqh Suz z olfo Poznan Poland
Shtpfnumflkgie ar Rtjpuemyyy Hanover Germany
Ajkjtfbeed Pzslword Hmmgyash Dw Pvami Paris France
Aywafkf Oxakiaxyiiy Nuqbuhofo Sy Aicmiql E Brburo E C Aonoba Alpfyhbmsjy Alexandria Italy
Hjuzhy Kqyjubwt Esqdkx Gxqo Erfurt Germany
Ujgakahsvrznpjeuljnel Argutndd Augsburg Germany
Hnnxyksj Unequodauappr Idrhppa Lgarco Madrid Spain
Gjwdr Giznzdtyiewr fjjt oypdobuczulk Sckreyr Dkojniog mdi Dortmund Germany
Pxrgmo Slbc Skorzewo Poland
Nyvuqzfo Ilohlflz Ontyirlag Idj Memkl Skralczqicmealrwtyxotzfbbnby Igwwbqjn Btoemyxd Cracow Poland
Uzpmcgzeocofahmxwofvw Wwtrqdhsy Ath Wuerzburg Germany
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
14.07.2025
France France
Recruiting
14.07.2025
Germany Germany
Recruiting
14.07.2025
Greece Greece
Recruiting
14.07.2025
Italy Italy
Recruiting
14.07.2025
Poland Poland
Recruiting
14.07.2025
Spain Spain
Recruiting
14.07.2025
The Netherlands The Netherlands
Recruiting
14.07.2025

Trial locations

Golcadomide is an experimental medication being studied for the treatment of relapsed or refractory follicular lymphoma (a type of blood cancer that affects the lymphatic system). It is being tested in combination with rituximab to see if it can help patients whose cancer has returned or not responded to previous treatments.

Rituximab is an approved medication that works by targeting a specific protein (CD20) found on the surface of certain white blood cells called B cells, including the cancerous B cells in follicular lymphoma. It helps the immune system identify and destroy these cancer cells.

Relapsed/Refractory Follicular Lymphoma – A form of non-Hodgkin lymphoma that has returned after initial treatment (relapsed) or has not responded adequately to treatment (refractory). Follicular lymphoma affects the B lymphocytes within the lymphatic system, causing them to abnormally multiply and build up in lymph nodes. The disease typically progresses slowly with enlarged lymph nodes, fatigue, night sweats, and weight loss as common symptoms. As it advances, the lymphoma can spread to other lymph nodes, bone marrow, spleen, and other organs. This disease follows a pattern of remissions and relapses, with each subsequent remission potentially being shorter than the previous one.

Trial ID:
2024-519152-82-00
Protocol code:
CA073-1003
Trial Phase:
Therapeutic confirmatory (Phase III)

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