Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma

Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study ID
NCT07126236
Phase
PHASE2
Status
Recruiting
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Conditions

  • Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

phase II, response-adaptive, open-label, multicenter study aiming to include 80 patients in 78 months. Patients will receive 3 cycles of epcoritamab monotherapy and, since cycle 4, they can continue with epcoritamab monotherapy until cycle 12 or change to combination therapy (epcoritamab + tafasitamab + lenalidomide) until cycle 15. Patients will be followed up to 5 years.

Key Dates

Start date
Aug 4, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EPCO monotherapy
    Epcoritamab in monotherapy will be administred until cycle 12.
  • Experimental: Combination therapy
    3 cycles of Epcoritamab in monotherapy will be administred and then Epcoritamab will be administred with Tafasitamab and Lenalidomide from cycle 4 until cycle 15.

Primary Outcome Measure

Efficacy of Epcoritamab monotherapy [ Time Frame: Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days. ]

Central Contacts

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