Golcadomide + Rituximab for Follicular Lymphoma

Recruiting at 144 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

Trial Summary

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.

What data supports the effectiveness of the drug combination Golcadomide + Rituximab for treating follicular lymphoma?

Research shows that adding rituximab to chemotherapy significantly improves outcomes for patients with follicular lymphoma, reducing the risk of treatment failure and prolonging survival. Rituximab has been effective in combination with other drugs for similar conditions, suggesting potential benefits when combined with Golcadomide. ^{1 2 3 4 5}

Is the combination of Golcadomide and Rituximab safe for treating follicular lymphoma?

Rituximab, when used alone or with chemotherapy, is generally well-tolerated, with common side effects being mild infusion reactions. Long-term use can lead to B-cell depletion, but no unexpected toxicities have been observed. Further research is needed to fully understand the long-term effects. ^{6 7 8 9 10}

How is the drug Golcadomide + Rituximab unique for treating follicular lymphoma?

The combination of Golcadomide and Rituximab for follicular lymphoma is unique because it pairs Rituximab, a monoclonal antibody that targets B-cell lymphomas, with Golcadomide, potentially offering a novel mechanism of action or enhanced efficacy compared to existing treatments like Rituximab with chemotherapy. ^{1 4 11 12 13}

What is the purpose of this trial?

The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Research Team

Bristol Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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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

Findings from Research

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]

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]

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]

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, 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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Germany pubmed.ncbi.nlm.nih.gov

[Increased response rate with rituximab in relapsed and refractory follicular and mantle cell lymphomas -- results of a prospective randomized study of the German Low-Grade Lymphoma Study Group]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Long-term follow up of the FL2000 study comparing CHVP-interferon to CHVP-interferon plus rituximab in follicular lymphoma. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Rituximab for the treatment of follicular lymphoma. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Safety of rituximab maintenance therapy in follicular lymphomas. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Phase II trial of galiximab (anti-CD80 monoclonal antibody) plus rituximab (CALGB 50402): Follicular Lymphoma International Prognostic Index (FLIPI) score is predictive of upfront immunotherapy responsiveness. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Rituximab and its role as maintenance therapy in non-Hodgkin lymphoma. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma: results of a phase II trial of rituximab. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Rituximab therapy in malignant lymphoma. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Evolving role of rituximab in the treatment of patients with non-Hodgkin's lymphoma. [2015]

13. France pubmed.ncbi.nlm.nih.gov

[Anti-CD20 in hematologic oncology]. [2016]