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Golcadomide + Rituximab for Follicular Lymphoma (GOLSEEK-2 Trial)

Phase 2
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of at least one of the following B symptoms: Fever (>38°C) of unclear etiology, Night sweats, Weight loss greater than 10% within the prior 6 months
Splenomegaly with inferior margin below the umbilical line
Must not have
Clinical evidence of transformed lymphoma by investigator assessment
Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years from randomization of last participant
Awards & highlights

Summary

"This trial aims to see how well golcadomide, when used together with rituximab, works in treating patients who have recently been diagnosed with advanced stage Follicular Lymphoma."

Who is the study for?
This trial is for adults with newly diagnosed advanced stage Follicular Lymphoma (grades 1, 2, or 3a) who haven't had systemic treatment. They can have had radiation or surgery if it was for stage I disease. Participants must show symptoms like large masses, fever, night sweats, weight loss over 10%, low blood counts due to lymphoma, or organ compression.
What is being tested?
The study tests the effectiveness and safety of a new drug combo: Golcadomide with Rituximab versus standard treatments (Prednisone, Vincristine, Bendamustine, Doxorubicin & Cyclophosphamide). It aims to see how well this new mix works in treating Follicular Lymphoma compared to existing therapies.
What are the potential side effects?
Possible side effects include allergic reactions to medication components; lowered blood cell counts leading to increased infection risk; nausea; hair loss; fatigue; and potential damage to organs such as the heart or liver from chemotherapy drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced fever, night sweats, or significant weight loss without a clear reason.
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My spleen is enlarged and extends below my belly button.
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My condition is between stage II and IV.
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I have a condition causing pressure or blockage in parts of my body.
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I have fluid buildup in my chest or abdomen.
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My lymphoma is confirmed as Grade 1, 2, or 3a follicular type.
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My cancer involves a large tumor or multiple sites.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lymphoma has changed into a more aggressive form.
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My lymphoma is classified as Follicular Large Cell or Grade 3b.
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I do not have any health issues that would stop me from joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years from randomization of last participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years from randomization of last participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
Secondary outcome measures
Best Overall Response (OR)
Complete Metabolic Response at 12 months from the randomization (CMR12)
Complete Metabolic Response at 6 months from the randomization (CMR6)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Rituximab + ChemotherapyExperimental Treatment6 Interventions
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Group II: Golcadomide Dose 2 + RituximabExperimental Treatment2 Interventions
Group III: Golcadomide Dose 1 + RituximabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~3240
Prednisone
2014
Completed Phase 4
~2500
Cyclophosphamide
2010
Completed Phase 4
~2320
Rituximab
1999
Completed Phase 4
~2200
Doxorubicin
2012
Completed Phase 3
~8030
Vincristine
2003
Completed Phase 4
~2970

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
130,459 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,559 Previous Clinical Trials
3,383,626 Total Patients Enrolled
~60 spots leftby Nov 2026
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