WHO ICTRP trial
A Study to Compare the Efficacy and Safety of Golcadomide Plus R-CHOP vs Placebo…
CTRI/2025/02/080620 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2025/02/080620 |
|---|---|
| Public title | A Study to Compare the Efficacy and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants with Previously Untreated High-risk Large B-cell Lymphoma |
| Scientific title | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants with Previously Untreated High-risk large B-cell Lymphoma (GOLSEEK-1) - GOLSEEK-1 |
| Primary sponsor | Bristol Myers Squibb India Pvt. Ltd. |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | France;Germany;Japan;Poland;Republic of Korea;Romania;Spain;Taiwan;United States of America;India;Belgium;Denmark;Italy;Netherlands;Switzerland;United… |
| Conditions | Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma |
| Interventions | Intervention1: Golcadomide(BMS-986369/CC-99282) Plus R-CHOP: 1) Drug: Golcadomide, Route of Administration: PO, Intervention Dose: 0.4mg once daily, Dosing Day(s)(21-day cycle): 1-7 2)Drug: Rituximab Route of Administration: IV/SC… |
| Registration date | Feb 14, 2025 |
| Target size | 850 |
| Secondary IDs | 2023-510178-15;CA0731020 Version No. 01 Protocol Date 15-Feb- 2024;U1111-1300-8493 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: