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Alkylating agents

Golcadomide + R-CHOP for B-Cell Lymphoma (GOLSEEK-1 Trial)

Phase 3
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 67 months
Awards & highlights

Summary

This trial aims to see if adding golcadomide to R-CHOP chemotherapy is more effective and safe than R-CHOP chemotherapy alone in patients with a specific type of lymphoma.

Who is the study for?
This trial is for adults with a new diagnosis of high-risk large B-cell lymphoma, including several specific subtypes. Participants must have an IPI score indicating moderate to high risk and measurable disease by certain medical imaging criteria. They cannot join if they have other types of lymphoma, CNS involvement by the lymphoma, or any condition that could interfere with their participation.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of Golcadomide combined with R-CHOP chemotherapy versus a placebo combined with R-CHOP in treating patients who haven't been treated before for high-risk large B-cell lymphoma.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, hair loss, fatigue, increased infection risk; plus any additional risks associated with Golcadomide which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 67 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 67 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) assessed by the Investigator
Secondary outcome measures
Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)
Complete metabolic response (CMR) assessed by the Investigator
Duration of response (DoR)
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)Experimental Treatment6 Interventions
Group II: Placebo + R-CHOPPlacebo Group6 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Prednisone
2014
Completed Phase 4
~2370
Vincristine
2003
Completed Phase 4
~2910
Rituximab
1999
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
643 Previous Clinical Trials
129,262 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,536 Previous Clinical Trials
3,374,957 Total Patients Enrolled
~567 spots leftby Aug 2028