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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years from randomization of last participant

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.