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Epcoritamab Plus Lenalidomide in Relapsed/Refractory Large B-cell Lymphoma After Second-Line CAR T-cell Therapy

ConditionsRefractory Diffuse Large B-Cell Lymphoma (DLBCL)Refractory Large B-cell Lymphoma (LBCL)Refractory T-cell/Histiocyte-rich Large B-cell LymphomaRefractory Transformed Follicular LymphomaRefractory High-Grade B-Cell LymphomaRefractory Follicular Lymphoma Grade 3B
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Lymphoma Academic Research Organisation

About this trial

The goal of this Phase 2, open-label, multicenter clinical trial is to assess the efficacy and safety of accelerated ramp-up and fixed-dose subcutaneous epcoritamab combined with lenalidomide in adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) following progression after second-line CAR T-cell therapy.

The main question it aims to answer is :

\- What is the overall response rate (ORR) after Cycle 2, or at premature treatment discontinuation (PTD), according to the 2014 Lugano Response Criteria?

Participants will:

* Receive subcutaneous epcoritamab administered according to an accelerated ramp-up schedule followed by fixed dosing, in combination with lenalidomide. * Undergo clinical evaluations, laboratory assessments, and PET-CT imaging to determine disease status based on the 2014 Lugano Response Criteria. * Continue study therapy for up to 48 weeks. * Enter a follow-up period of at least 24 months after the last dose to monitor long-term outcomes and safety.

Approximately 55 adults will be enrolled across multiple centers in France. Eligible individuals must have R/R LBCL, including diffuse large B-cell lymphoma and other eligible LBCL subtypes, with progressive metabolic disease documented by PET-CT at least 1 month after second-line CAR T-cell therapy. The overall study duration is expected to be approximately 5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant (or their legally acceptable representative / trusted person) who understand and voluntarily signs and dates an informed consent form prior to any study-specific assessments/procedures being conducted

Aged ≥ 18 years at the time of signing the informed consent form (ICF) with no upper age limit

Diffuse large B-cell lymphoma (DLBCL), NOS

Large B-cell lymphoma (LBCL)

Disqualifiers

Previously known CD20 negative status, excepted if a new biopsy or cytometry analysis proving a CD20 positive status is available before enrollment

Prior solid organ transplantation

Prior allogeneic SCT

Autologous SCT within 100 days prior to epcoritamab infusion

Trial design

Design model

Single group

Treatments tested in this trial

  • Epcoritamab

    Drug

    Epcoritamab will be administered subcutaneously in combination with lenalidomide. During Cycle 1, participants will receive an accelerated ramp-up dosing schedule consisting of 0.16 mg on Day 1, 0.8 mg on Day 3, and 48 mg on Days 8, 15, and 22. During Cycle 2, participants will receive 48 mg once weekly on Days 1, 8, 15, and 22. During the consolidation phase (Cycles 3 to 12), participants will receive 48 mg subcutaneously on Day 1 of each 28-day cycle.

  • Lenalidomide

    Drug

    Lenalidomide will be administered orally in combination with epcoritamab from Cycles 2 through 12. Lenalidomide will be given once daily on Days 1 to 21 of each 28-day cycle, followed by a 7-day rest period (Days 22 to 28). The starting dose will be 20 mg for participants with creatinine clearance (CrCL) ≥60 mL/min and 10 mg for participants with CrCL between 30 and \<60 mL/min, according to the study protocol.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Epcoritamab plus LenalidomideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Overall response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to the 2014 Lugano Response Criteria following treatment with accelerated ramp-up dosing and fixed-dose epcoritamab in combination with lenalidomide.

Time frame
At the end of Cycle 2 (each cycle is 28 days) or until premature treatment discontinuation (PTD) from any cause, whichever occurs first, assessed up to 56 days

Secondary outcomes

1

Best Overall Response Rate (Best ORR)

Best overall response rate (Best ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as their best overall response according to the 2014 Lugano Response Criteria during study treatment.

Time frame
From Cycle 1 through the end of Cycle 8 (each cycle is 28 days) or until premature treatment discontinuation (PTD) from any cause, whichever occurs first, assessed up to 224 days.
2

Complete Metabolic Response (CMR) Rate

Proportion of participants achieving a complete metabolic response (CMR) according to the 2014 Lugano Response Criteria.

Time frame
At Cycles 1, 2, 5, 8, and 12 (each cycle is 28 days), assessed up to 336 days.
3

Duration of Response (DoR)

Duration of response (DoR), defined as the time from the first documented complete metabolic response (CMR) or partial metabolic response (PMR) according to the 2014 Lugano Response Criteria until the first documented disease progression, relapse, or death from any cause.

Time frame
From the date of first documented partial or complete response until the date of first documented disease progression, relapse, or death from any cause, whichever occurs first, assessed up to 54 months ( end of follow-up).
4

Progression-Free Survival (PFS)

Progression-free survival (PFS), defined as the time from the first dose of study treatment to the first documented disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first.

Time frame
From date of Cycle 1 (each cycle is 28 days)until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 54 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Lymphoma Academic Research Organisation

Lead sponsor

AbbVie

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: