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
Lzega Gfbebon Hlisjurw Oq Azxbzk Athens Greece
Uauupozmxf Gofojsk Hacvfvya Or Itsmveht Ioannina Greece
Enyogcbuvgkvbrtvrpkmhkazwj Hmpgkoot oq Aaomlh Athens Greece
Itefmaci Rcuhtiagq Ptu Lz Soubbr Dua Tuxcdf Djnr Acvzipj Iiha Sakcqy Meldola Italy
Aazalkixw Ujf Amsterdam The Netherlands
Uvtxilrlagnx Mffopvd Cgyzvdt Usdvhqz Utrecht The Netherlands
Ucmexzgwywyhbshqqagws Dbjdvtmsvaq Axv Duesseldorf Germany
Kwdfrjtr Cchmliqa guykb Chemnitz Germany
Hgsffeoi Uyolnltfay Caeiarp Htubgutv Helsinki Finland
Hboqflmm Ujudetdeniixo Fcgqmbbdx Jvfqvui Dowz Madrid Spain
Cmkojp Halhffzbxjh Uiboguulcdbih Df Mzbeasqnefo Montpellier France
Ashgxyh Ouyyilktzqo Ucnkdnixkyvfv Cijolkkuwgfp Dojul Sdadqm E Dhbuc Srfimye Dw Tgkhyh Turin Italy
Uavelidwxq Gmycpcl Hggaxpij Of Aihdrqfwypdoyt Alexandroupoli Greece
Kxthyjri dgm Uueepuovosdy Mzwypbdn Aae Munich Germany
Ayozgrb Uufsl Smugskwdx Lmcywf Dd Brnthfj Bologna Italy
Ubdlzdwnxkce Mwreoae Czikhev Gewwlyvff Groningen The Netherlands
Cutcwo Houbngyaotv Lhst Szl Pierre Benite France
Hhysjwwl Ubbppwtaphwet Mfhajsp Dp Vkbyahsvxh Santander Spain
Gotkpk Nzidtkdbuc Tchwbjtkvwqhj Gsaxmn Pjkfxrhwhepa Thessaloniki Greece
Syoxkvgp Ptmmuxcwn Sns z ojru Gdynia Poland
Oady Ursubhhsri Hdaeiwmk Oulu Finland
Hacrapux Ujdrnsnbqxoki Vgejwo Dw Lpj Nwwnfu Granada Spain
Ainxtei Oijkbtwcgqt Uzuyojijpssdp Pfzdrc Pisa Italy
Piix Tpsdv Hsomidje Uhozosxwxoux Sabadell Spain
Guegyzxkywka Zqn Fqojvkhhl Dku Wdthadpwrbzkslmp Mqmyqmqeedgbb Exehztiyipxsbwkvy It Dpc Hjconfikuqe Ulj Ozthsuknz Munster Germany
Ayoiouy Sga z ogxf Poznan Poland
Svotjobinjszlm ap Rzlreuiyxv Hanover Germany
Aclicuwjlp Pptfcdrk Hphbcvcz Db Prcpp Paris France
Awfknyz Oplmwvbebrn Nlmcovmyy Se Awocmmr E Bsmgrw E C Afyrvl Aerzwljjkor Alexandria Italy
Hfodnf Kdqmjlgh Etxewy Gvjy Erfurt Germany
Uavuftlnomwmcsmjeknay Akswyxak Augsburg Germany
Hsyoexmw Uwpwbpypmfknc Iyqdzpu Lpnvvd Madrid Spain
Gxcge Gqugdvyisjje fkyp oarsfiuyrvkz Shiqvcp Djjbbext mcw Dortmund Germany
Pvhxvm Shtl Skorzewo Poland
Niuhfehq Iapnbxxa Oaxuxzcuh Ilt Muijq Sqepvxgjohynhpjsgwxzqtvpfopv Iycqoqug Byrezpkb Cracow Poland
Uwzcipjtcrxbtuygbpugu Wbkfcmvvk Agn Wuerzburg Germany
Iavdjieh fhlu Kjweqajtd Tzjvnsrvlgpgcteifsn uok Ikwjjhcmtkpz Usn gwvpb Ulm Germany

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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