Golcadomide + Rituximab for Follicular Lymphoma

Recruiting at 226 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Celgene

Must be taking: Anti-CD20 antibodies

Disqualifiers: CNS involvement, Stroke, DVT/PE, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new combination of drugs, golcadomide (an experimental treatment) and rituximab, for treating follicular lymphoma that has recurred or not responded to treatment. Researchers compare this new combination to other standard treatments to determine which is more effective and safe. Individuals with follicular lymphoma who have undergone at least one previous treatment and still have active disease may qualify for this study. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of golcadomide and rituximab is generally safe for patients with relapsed or refractory follicular lymphoma. Studies have found that this treatment can be effective without causing serious side effects for most people.

Rituximab, one of the drugs in this combination, is already approved for other uses, so its safety profile is well understood. While some side effects might occur, they are usually manageable. Patients should always discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Golcadomide combined with Rituximab for treating follicular lymphoma because it introduces a potentially new mechanism of action. While standard treatments like R-CHOP and Rituximab with Lenalidomide target lymphoma cells primarily through established pathways, Golcadomide may offer an innovative approach that enhances the immune system's ability to fight cancer. This combination could potentially improve efficacy and help overcome resistance that some patients experience with current therapies. By integrating Golcadomide, this treatment aims to provide a more targeted attack on lymphoma cells, potentially leading to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for follicular lymphoma?

Studies have shown that using golcadomide with rituximab, which participants in this trial may receive, effectively treats follicular lymphoma that has returned or is unresponsive to other treatments. This combination has demonstrated long-lasting effects, with benefits continuing over time. It is also considered well tolerated, meaning most patients can undergo the treatment without severe side effects. Other research has shown that golcadomide used with chemotherapy effectively fights tumors. This suggests that golcadomide, especially when combined with rituximab, could be a promising option for those dealing with this type of lymphoma. Another arm of this trial will compare the effectiveness of rituximab combined with lenalidomide or chemotherapy regimens, such as R-CHOP or rituximab with bendamustine. ^{1 2 3 6 7}

Who Is on the Research Team?

Bristol Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with follicular lymphoma who have tried at least one treatment before. Participants should be in good enough health to receive the study treatments. Specific details about what conditions exclude someone from participating are not provided here.

Inclusion Criteria

Lab parameters: ANC ≥ 1,000 cells/mm3, PLT count ≥ 75,000 cells/mm3, Hb ≥ 7.5 g/dL, eGFR ≥ 30 ml/min/1.73m², AST/SGOT or ALT/SGPT ≤ 2.5 x ULN, serum total bilirubin ≤ 1.5 × ULN, LVEF ≥ 40%

I've had treatment that included an anti-CD20 drug and a chemotherapy agent.

My follicular lymphoma has either come back after treatment or didn't respond well to the last treatment.

Exclusion Criteria

Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent compliant participation in the study

Participant has any condition that confounds the ability to interpret data from the study

Other protocol-defined Inclusion/Exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Golcadomide in combination with Rituximab or investigator's choice of treatment

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bendamustine
• Doxorubicin
• Rituximab

Trial Overview The GOLSEEK-4 study is testing golcadomide combined with rituximab against a choice of other approved drugs for relapsed/refractory follicular lymphoma. It's a Phase 3 trial, meaning it's looking at how well the new drug works and checking its safety.

How Is the Trial Designed?

Group I: Golcadomide + Rituximab Experimental Treatment 2 Interventions

Group II: Rituximab + Lenalidomide/Chemotherapy Active Control 7 Interventions

Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

Rituximab, an anti-CD20 antibody, has been shown to be effective in treating various B-cell lymphoid malignancies, with benefits including improved response rates and progression-free survival, based on extensive clinical data since its introduction in 1997.

The drug is generally well-tolerated, with infusion-related side effects being the most significant, and its use has expanded from treating relapsed low-grade lymphomas to first-line therapy and more aggressive forms like diffuse large B-cell lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab and its role as maintenance therapy in non-Hodgkin lymphoma. Collins-Burow, B., Santos, ES.[2015]

Rituximab is a highly effective monoclonal antibody for treating various B-cell lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, demonstrating a strong activity with low toxicity.

The combination of rituximab with chemotherapy (R-CHOP) has shown the highest efficacy reported for any chemotherapy regimen in treating diffuse large B-cell lymphoma and follicular lymphoma, although some patients may still be resistant to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab therapy in malignant lymphoma. Coiffier, B.[2022]

Rituximab is the first monoclonal antibody approved for treating B-cell lymphomas, showing significant effectiveness in conditions like follicular lymphoma, mantle cell lymphoma, and diffuse large B-cell lymphoma.

The combination of rituximab with standard chemotherapy agents (cyclophosphamide, doxorubicin, vincristine, and prednisone) has achieved the highest efficacy reported for treating diffuse large B-cell lymphoma and follicular lymphoma, while maintaining low toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving role of rituximab in the treatment of patients with non-Hodgkin's lymphoma. Traullé, C., Coiffier, BB.[2015]

Rituximab, when combined with chemotherapy (specifically cyclophosphamide, vincristine, and prednisone), has been approved as a front-line treatment for follicular lymphoma, showing significant benefits in progression-free survival and overall survival based on randomized Phase III studies.

The review highlights that the addition of rituximab to chemotherapy regimens not only improves patient outcomes but also represents a significant advancement in the management of follicular lymphoma over the past three decades.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on front-line therapy for follicular lymphoma: chemo-immunotherapy with rituximab and survival. Turturro, F.[2015]

Rituximab, an anti-CD20 monoclonal antibody, demonstrated a 43% overall response rate in a phase II trial involving 31 patients with bulky relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma, indicating its efficacy as a treatment option.

The treatment was well-tolerated, with no patients discontinuing due to adverse events, and it showed a median time to progression of 8.1 months, highlighting its safety and potential for managing this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma: results of a phase II trial of rituximab. Davis, TA., White, CA., Grillo-López, AJ., et al.[2022]

In a study of 428 patients with untreated advanced-stage follicular lymphoma, adding rituximab to the standard CHOP chemotherapy significantly reduced the risk of treatment failure by 60% and improved overall survival rates.

While the combination therapy (R-CHOP) led to a higher incidence of myelosuppression, severe infections remained rare, indicating that rituximab can enhance treatment efficacy without causing major safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Hiddemann, W., Kneba, M., Dreyling, M., et al.[2022]

In a study involving 1030 patients with previously untreated follicular lymphoma, the combination of rituximab and lenalidomide showed similar efficacy to rituximab plus chemotherapy, with complete response rates of 48% and 53% respectively at 120 weeks.

The safety profiles differed between the two treatments, with rituximab-chemotherapy leading to higher rates of severe neutropenia, while rituximab-lenalidomide was associated with more severe skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. Morschhauser, F., Fowler, NH., Feugier, P., et al.[2021]

Rituximab, an anti-CD20 monoclonal antibody, significantly improves outcomes for patients with B-cell malignancies, both as a standalone treatment and in combination with chemotherapy, leading to better response rates and survival.

While rituximab enhances progression-free survival, it also increases the risk of infections, prompting its use as a maintenance therapy after initial treatment, although some patients may develop resistance to the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab for the treatment of follicular lymphoma. Cheah, CY., Lingaratnam, S., Seymour, JF.[2015]

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/3018/533620/Golcadomide-GOLCA-Rituximab-RTX-Demonstrates

Golcadomide (GOLCA) ± Rituximab (RTX) Demonstrates ... Golcadomide (GOLCA) ± Rituximab (RTX) demonstrates durable efficacy and is well tolerated in patients (pts) with relapsed/refractory follicular lymphoma (R/R ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06425302

NCT06425302 | A Study to Evaluate the Efficacy and ... The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124091390

Golseek-2: A Phase 2 Randomized, Open-Label Study to ... A randomized phase 2 trial assessing the efficacy and safety of GOLCA-R as a chemo-free option in pts with newly diagnosed advanced-stage FL.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12081106/

Follicular lymphoma: contemporary clinical management with ... In the pre-rituximab era, long-term follow-up data from the Dana-Farber Cancer Institute showed an 8-year disease-free survival rate of 42% and an OS rate of 66 ...

5. onclive.com onclive.com/view/frontline-golcadomide-r-chop-combo-elicits-antitumor-activity-in-aggressive-b-cell-lymphoma

Frontline Golcadomide/R-CHOP Combo Elicits Antitumor ... Golcadomide given at 0.4 mg plus R-CHOP elicited a high rate of metabolic responses in patients with previously untreated aggressive B-cell lymphoma.

6. ash.confex.com ash.confex.com/ash/2023/webprogram/Paper188771.html

Efficacy and Safety of Golcadomide, a Novel Cereblon E3 ... Here, we report efficacy and safety results for golcadomide + rituximab in patients with DLBCL treated in Part B expansion on a 14 days on/14 ...

7. clinicaloptions.com clinicaloptions.com/activities/oncology/latest-data-on-celmods-in-nhl/80596/content

Latest Data on CELMoDs in NHL Recent data from trials of the CELMoD golcadomide showed promising activity and manageable safety in patients with relapsed/refractory non- ...