In short
Clinical trials are studying Golcadomide in several blood cancers, especially different types of lymphoma. These studies look at safety, effectiveness, and the best dose or treatment plan in people with newly diagnosed, relapsed, or hard-to-treat disease.
Key points
- Golcadomide is being studied in several clinical trials for different types of lymphoma, including follicular lymphoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, and lymphoma in the brain. The trials include Phase 1, Phase 2, and Phase 3 studies, so the research ranges from early safety testing to larger comparisons of treatment benefit. Some studies focus on people whose disease is relapsed or refractory, meaning it came back or did not respond well, while others study newly diagnosed or high-risk patients. Several trials test Golcadomide with other cancer treatments such as rituximab or R-CHOP. The main outcomes include progression-free survival, complete metabolic response, best overall response, and dose-related safety measures.
Overview of the Golcadomide trials
These studies are testing Golcadomide in people with several kinds of lymphoma, which is a cancer of the lymph system. The research includes both early and later studies, so the trials are checking safety, dose, and how well the treatment works.
Some trials use Golcadomide alone, and others test it with other cancer medicines such as rituximab or R-CHOP. The target groups include people with newly diagnosed disease, relapsed disease, refractory disease, high-risk disease, and older frail patients.
Conditions being studied
The trials cover a wide range of lymphoma types. These include follicular lymphoma, diffuse large B-cell lymphoma, large B-cell lymphoma in the brain, and peripheral T-cell lymphomas.
Some studies also include people with relapsed or refractory non-Hodgkin lymphoma, which means the cancer came back or did not respond to treatment. One study looks at people after anti-CD19 CAR T-cell infusion, which is a special cell therapy already given before Golcadomide is studied.
Trial phases and what they mean
The Golcadomide program includes Phase 1, Phase 2, and Phase 3 trials. Phase 1 studies are mainly about safety, tolerability, and dose-finding, while Phase 2 and Phase 3 studies focus more on how well the treatment works in the chosen patient group.
For example, the Phase 1 platform study in relapsed or refractory peripheral T-cell lymphomas is looking for the maximum tolerated dose and the recommended Phase 2 dose. The Phase 3 studies compare Golcadomide-based treatment against another treatment plan or placebo-based treatment in larger groups.
Who can participate
Each trial has its own entry rules, but all are focused on people with specific lymphoma types. Some trials are for people whose disease is relapsed/refractory, while others are for people with newly diagnosed disease or high-risk disease.
One study is designed for older, frail patients who are not candidates for standard R-CHOP or similar treatment. Another study focuses on people with central nervous system lymphoma, including primary and secondary forms, which means the cancer is in or has spread to the brain area.
Main endpoints being measured
The studies measure different endpoints, which are the main results used to judge the trial. Common endpoints include progression-free survival, best overall response, complete metabolic response, and time to disease progression or death.
Some studies also measure dose-limiting toxicities, maximum tolerated dose, and recommended Phase 2 dose, which help researchers find the safest and most useful dose plan. In the brain lymphoma study, the main result is the best overall response during the first 13 treatment cycles, with complete and partial remission used to judge response.
How Golcadomide is being tested
Golcadomide is studied both as a single treatment and in combination with other anti-lymphoma medicines.
- With rituximab: several trials test Golcadomide together with rituximab in follicular lymphoma and diffuse large B-cell lymphoma.
- With R-CHOP: one large Phase 3 study compares Golcadomide plus R-CHOP with placebo plus R-CHOP in previously untreated high-risk large B-cell lymphoma.
- After CAR T-cell therapy: one Phase 2 study gives Golcadomide after anti-CD19 CAR T-cell infusion to see whether it can improve response in patients at high risk of relapse.
- In platform studies: one trial uses a platform design, which means several treatment options are tested in the same study structure for relapsed or refractory peripheral T-cell lymphomas.
List of key studies
The table below shows the main Golcadomide trials found in the source data.
| Trial ID | Phase | Condition | Main goal | Status | Enrollment |
|---|---|---|---|---|---|
| 2023-510178-15-00 | Phase 3 | Previously untreated high-risk large B-cell lymphoma | Compare Golcadomide plus R-CHOP with placebo plus R-CHOP and measure progression-free survival | Authorised | 930 |
| 2024-519152-82-00 | Phase 3 | Relapsed/refractory follicular lymphoma | Compare Golcadomide with rituximab versus investigator’s choice and measure time to progression or death | Authorised | 400 |
| 2024-511304-16-00 | Phase 2 | Newly diagnosed advanced stage follicular lymphoma | Measure complete metabolic response | Authorised | 150 |
| 2024-517051-12-00 | Phase 2 | Primary, relapsed, or refractory central nervous system large B-cell lymphoma | Measure best overall response in the first 13 treatment cycles | Authorised | 74 |
| 2023-506705-20-00 | Phase 2 | Relapsed/refractory aggressive large B-cell lymphoma after CAR T-cell therapy | Measure complete metabolic response at 3 months after infusion | Authorised | 61 |
| 2024-514954-63-00 | Phase 1 | Relapsed/refractory peripheral T-cell lymphomas | Find the maximum tolerated dose and recommended Phase 2 dose; later measure modified progression-free survival | Authorised | 80 |
| 2023-506206-38-00 | Phase 2 | Older frail patients with diffuse large B-cell lymphoma | Measure progression-free survival with a chemo-free approach | Authorised | 47 |
| NCT03930953 | Phase 1 | Relapsed or refractory non-Hodgkin lymphomas | Check safety, tolerability, dose-limiting toxicities, and recommended Phase 2 dose | Authorised | 438 |
| NCT05283720 | Phase 1 | Non-Hodgkin lymphoma, including diffuse large B-cell lymphoma | Check safety and tolerability of epcoritamab with anti-neoplastic agents; Golcadomide is one of the study drugs | Authorised | 133 |