27 Participants Needed

Epcoritamab + Lenalidomide + Tafasitamab for Lymphoma

(ECLAT Trial)

Recruiting at 6 trial locations
PT
Overseen ByPallawi Torka, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Aspirin, Anticoagulant
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of three drugs to determine their safety and effectiveness in treating certain types of lymphoma that have returned or are unresponsive to treatment. The drugs under investigation are epcoritamab, lenalidomide, and tafasitamab. Individuals who have undergone at least two previous unsuccessful treatments for their lymphoma may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to potentially benefit from an innovative therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

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

A previous study found the combination of tafasitamab and lenalidomide to be generally safe for patients with large B-cell lymphoma. While some patients experienced side effects, the treatment was mostly well-tolerated. About 54% of patients had at least one significant side effect, with neutropenia, a low white blood cell count, being the most common. Doctors can monitor and manage this condition.

Epcoritamab, when combined with other treatments, has shown positive effectiveness. However, specific safety information for its combination with tafasitamab and lenalidomide is not detailed in the sources. Since tafasitamab and lenalidomide have been well-studied and the trial is in Phase 2, some established safety evidence exists. This suggests the combination is expected to be relatively safe, though side effects should be monitored. Always consult a healthcare provider to understand the risks.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Epcoritamab, Lenalidomide, and Tafasitamab for lymphoma because it offers a unique multi-pronged approach to tackling cancer cells. Unlike standard treatments, Epcoritamab is a bispecific antibody that targets CD3 and CD20, potentially enhancing the body's immune response directly against lymphoma cells. Tafasitamab, another antibody, targets CD19, adding another layer of attack on the cancer. Meanwhile, Lenalidomide boosts the immune system and attacks cancer cells, offering a comprehensive strategy that could improve outcomes compared to existing therapies. This combination may provide a more robust and targeted assault on lymphoma, which is why it's generating excitement in the medical community.

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

Research has shown that using tafasitamab and lenalidomide together can effectively treat certain types of lymphoma. One study found that 57.5% of patients experienced a reduction or disappearance of their cancer, with many achieving a complete response, meaning no signs of cancer were found. In this trial, participants will receive a combination of epcoritamab, lenalidomide, and tafasitamab. Epcoritamab, when combined with lenalidomide and another drug, has demonstrated even better results in similar cases, significantly reducing the cancer. These findings suggest that this combination could be promising for people with relapsed or difficult-to-treat lymphoma.13467

Who Is on the Research Team?

PT

Pallawi Torka, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with Diffuse Large B Cell Lymphoma (DLBCL) who have tried other treatments that didn't work or the disease came back. Specific details about eligibility criteria are not provided, but typically participants need to meet certain health standards and may be required to follow specific protocols.

Inclusion Criteria

Ability to comply with all the study-related procedures, in the investigator's judgement
Contraception requirements
I do not currently have COVID-19, and if I had symptoms or was exposed, I tested negative.
See 18 more

Exclusion Criteria

I've had tafasitamab/lenalidomide for lymphoma but was in remission for 1+ year after.
My HIV is under control, or I don't have active hepatitis B or C.
I haven't had major surgery in the last 4 weeks or have fully recovered if I did.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Epcoritamab subcutaneously once weekly in cycles 1-3 and every 4 weeks in cycles 4-12, Tafasitamab intravenously once weekly during cycles 1-3 and every 2 weeks during cycles 4-12, and Lenalidomide orally daily on days 1-21 of a 28-day cycle

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Epcoritamab
  • Lenalidomide
  • Tafasitamab
Trial Overview The study tests a new combination of drugs: Epcoritamab, Lenalidomide, and Tafasitamab in patients with DLBCL. It aims to determine if this trio is safe and effective for those whose lymphoma has returned or resisted previous treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Epcoritamab with Lenalidomide and TafasitamabExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Genmab

Industry Sponsor

Trials
76
Recruited
15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Citations

Tafasitamab and lenalidomide in large B-cell lymphomaLenalidomide initiation delays occurred in 48% of patients; in patients with delays, median time between first tafasitamab and first ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40371897/
Clinical benefit of tafasitamab plus lenalidomide in ...Approval was based on the L-MIND study, which demonstrated a 57.5% overall response rate (ORR), 41.3% complete response (CR) rate, 12.1-month ...
Tafasitamab for patients with relapsed or refractory diffuse ...This final 5-year analysis of L-MIND demonstrates that the immunotherapy combination of tafasitamab and lenalidomide is well tolerated and has long-term ...
Matching-Adjusted Indirect Comparison of Epcoritamab ...After match-adjustment, epcoritamab+R2 provided significantly higher ORRs (95.9% vs 83.5%; P < 0.001) and CR rates (88.2% vs 52.0%; P < 0.001) compared with ...
Tafasitamab Plus Lenalidomide and Rituximab ...The median progression-free survival was substantially improved at 22.4 months for patients receiving tafasitamab vs 13.9 months in the placebo ...
Tafasitamab for the treatment of patients with diffuse large B ...Tafasitamab in combination with lenalidomide appeared to improve survival outcomes versus pola-BR and R2 (HR: 0.441; p = .034; (HR: 0.435; p ...
Reviewing Key Efficacy and Safety Data for Tafasitamab ...The majority of the AEs come during the combination of tafasitamab/lenalidomide and we may monitor patients for neutropenia, and with some ...
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