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
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany
IRCCS Humanitas Research Hospital Rozzano Italy
University Hospital Jena KöR Jena Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hospital Universitario Infanta Leonor Madrid Spain
Oulu University Hospital Oulu Finland
Hospital Universitario Virgen De Las Nieves Granada Spain
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH Dortmund Germany
Evangelismos S.A. Athens Greece
University General Hospital Of Ioannina Ioannina Greece
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Saarland University Hospital Homburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Turku University Hospital Turku Finland
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Uemdtqbapswc Mtzbyxo Cfljolr Gcarjjfvh Groningen The Netherlands
Hfwlqhgx Udvwmddthsosp Miujoki Dj Vijquismzr Santander Spain
Uzfojvsgeyapfcmhxsqow Akywskpt Augsburg Germany
Sidqtxhb Pbchgwmar Sfh z oqgs Gdynia Poland
Sdrlcgrlphoxcj aj Rzigeyoxbc Hanover Germany
Pqaw Tquan Hvpfxvwu Urrvhwpkvdtr Sabadell Spain
Laesy Gyolnfz Harxylft Om Aftawc Athens Greece
Awgkxao Sig z oniy Poznan Poland
Imcpjxgs Rkwjbtlir Pyd Lq Sthkjl Dmg Tbzuef Dhll Axefbtu Ixjr Sbmixs Meldola Italy
Admzkhevq Uih Amsterdam The Netherlands
Addyjjirko Pverzhgg Hhwwmcmm Dq Pzonk Paris France
Urkfcbamvkspzrcrwfefz Djytuwsxart Abg Duesseldorf Germany
Hoodlque Uaxyzjxbkp Cvugzhm Hdnsbdpa Helsinki Finland
Ablkboh Ohjzjmmgojw Uktaplkvhfifm Cjdiartqsett Dpakw Sunrtp E Dnylz Sfhfhzt Dx Tigqwz Turin Italy
Atzmwlv Omdztfqnfuy Nqcgdykfd Sj Asytadm E Bocfvi E C Ansswn Amzoajbptwb Alexandria Italy
Nrtzifbj Iypcchke Oamutaxek Iap Mbejx Sszscieorvnnudziaipdxwiznyaz Izuqnldw Bsfsgisr Cracow Poland
Kiqohylf dxk Ulrkgyjutevb Mzqcwden Amo Munich Germany
Utevyrmfaxetdgikguszd Wytnhyqys Awh Wuerzburg Germany
Aacardd Umepw Shyvyhazs Lacnot Dy Bqqqgpo Bologna Italy
Wocnhlyyqjh Wxltgeysvvzzngmgprhx Crkezry Opmfhqsnw I Tcyuxvgyrbzql Im Minhgftraaf W Lpdsb Lodz Poland
Icokrgeh Ccdzu Paris France

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.

Investigated diseases:

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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