Epcoritamab + Lenalidomide + Tafasitamab for Lymphoma

(ECLAT Trial)

Recruiting at 6 trial locations

Overseen By Pallawi Torka, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Aspirin, Anticoagulant

Must not be taking: CD3/CD20 BiAb, Tafasitamab, Lenalidomide

Disqualifiers: Active CNS involvement, Secondary malignancy, Uncontrolled HIV, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The researchers are doing this study to find out whether the combination of epcoritamab with tafasitamab and lenalidomide is a safe and effective treatment for relapsed or refractory DLBCL. This is the first time the combination of drugs is being tested.

Who Is on the Research Team?

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.

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.

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?

Group I: Epcoritamab with Lenalidomide and Tafasitamab Experimental Treatment 3 Interventions

Epcoritamab: Subcutaneous, once weekly in cycles 1-3; every 4 weeks cycles 4-12. Tafasitamab: Intravenous, once weekly during cycles 1-3, then every 2 weeks during cycle 4-12. Lenalidomide: Oral, daily on days 1-21 of a 28-day cycle.

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

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

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