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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510178-15-00

Acronym

CA073-1020

Enrollment

322

Registered

2024-07-15

Start date

2024-07-31

Completion date

Unknown

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Large B-cell Lymphoma

Brief summary

To evaluate the PFS. This is the time from when a person starts the trial until their disease gets worse or they pass away, whichever happens first.

Detailed description

To evaluate the OS. This is the time from when a person starts the trial until they pass away from any cause., To evaluate the EFS. This is the time from when a person starts the trial until one of the following happens: they pass away, their disease gets worse or comes back, they start a new treatment for their lymphoma, or they show signs of disease after finishing the treatment., To evaluate the CMR. This means that at the end of the treatment, the person's disease has completely responded to the treatment., To evaluate the MRD negativity. This means that at the end of the treatment, we can't detect any cancer DNA in the person's body.

Interventions

DRUGRITUXIMAB

DRUGCYCLOPHOSPHAMIDE MONOHYDRATE

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGPREDNISONE

DRUGPREDNISOLONE

DRUGGolcadomide

DRUGNeulasta 6 mg solution for injection

DRUGVINCRISTINE SULFATE

DRUGGolcadomide 0.2 mg capsule

DRUGGolcadomide 0.3 mg capsule

DRUGGolcadomide 0.4 mg capsule

DRUGAPIXABAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the PFS. This is the time from when a person starts the trial until their disease gets worse or they pass away, whichever happens first.	—

Secondary

Measure	Time frame
To evaluate the OS. This is the time from when a person starts the trial until they pass away from any cause., To evaluate the EFS. This is the time from when a person starts the trial until one of the following happens: they pass away, their disease gets worse or comes back, they start a new treatment for their lymphoma, or they show signs of disease after finishing the treatment., To evaluate the CMR. This means that at the end of the treatment, the person's disease has completely responded to the treatment., To evaluate the MRD negativity. This means that at the end of the treatment, we can't detect any cancer DNA in the person's body.	—

Measure

Time frame

—

Countries

Austria, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026