Table of Contents
- Overview of the Golcadomide trials
- Conditions being studied
- Trial phases and what they mean
- Who can participate
- Main endpoints being measured
- How Golcadomide is being tested
- List of key studies
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.[1] The research includes both early and later studies, so the trials are checking safety, dose, and how well the treatment works.[1][2]
Some trials use Golcadomide alone, and others test it with other cancer medicines such as rituximab or R-CHOP.[2][3] The target groups include people with newly diagnosed disease, relapsed disease, refractory disease, high-risk disease, and older frail patients.[2][4]
Conditions being studied
The trials cover a wide range of lymphoma types.[1] These include follicular lymphoma, diffuse large B-cell lymphoma, large B-cell lymphoma in the brain, and peripheral T-cell lymphomas.[1][2][3]
Some studies also include people with relapsed or refractory non-Hodgkin lymphoma, which means the cancer came back or did not respond to treatment.[5] One study looks at people after anti-CD19 CAR T-cell infusion, which is a special cell therapy already given before Golcadomide is studied.[4]
Trial phases and what they mean
The Golcadomide program includes Phase 1, Phase 2, and Phase 3 trials.[1][2] 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.[5][6]
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.[6] The Phase 3 studies compare Golcadomide-based treatment against another treatment plan or placebo-based treatment in larger groups.[2][7]
Who can participate
Each trial has its own entry rules, but all are focused on people with specific lymphoma types.[1] Some trials are for people whose disease is relapsed/refractory, while others are for people with newly diagnosed disease or high-risk disease.[2][3]
One study is designed for older, frail patients who are not candidates for standard R-CHOP or similar treatment.[8] 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.[9]
Main endpoints being measured
The studies measure different endpoints, which are the main results used to judge the trial.[1] Common endpoints include progression-free survival, best overall response, complete metabolic response, and time to disease progression or death.[2][3][7]
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.[5][6] 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.[9]
How Golcadomide is being tested
Golcadomide is studied both as a single treatment and in combination with other anti-lymphoma medicines.[2][3][5]
With rituximab: several trials test Golcadomide together with rituximab in follicular lymphoma and diffuse large B-cell lymphoma.[2][8]
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.[7]
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.[4]
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.[6]
List of key studies
The table below shows the main Golcadomide trials found in the source data.[1]
| 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 |
