Actively Recruiting
Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma
Led by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Updated on 2025-08-17
80
Participants Needed
15
Research Sites
330 weeks
Total Duration
On this page
Sponsors
G
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study assessments
- Age over 18 years
- Diagnosis of relapse or refractory Large B Cell Lymphoma, including Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, High-grade B-cell lymphoma, or grade 3B Follicular Lymphoma
- Relapse defined as disease recurrence at least 6 months after first-line therapy completion
- Refractory disease defined as no response or limited response to first-line therapy
- Received adequate first-line therapy including anti-CD20 antibody and CHOP or CHOP-like chemotherapy
- Not a candidate for first relapse CAR-T therapy or unwilling to receive it
- Ineligible for autologous stem cell transplantation or unwilling to receive transplant
- PET-positive disease
- Eastern Cooperative Oncology Group performance status 0 to 2
- Hematology values including hemoglobin ≥8 g/dl, absolute neutrophil count ≥1 x 10^9/L, absolute lymphocyte count ≥0.1 x 10^9/L, and platelet count ≥70 x 10^9/L (or ≥50 x 10^9/L if bone marrow involvement)
- Female patients of child-bearing potential must have negative pregnancy test and agree to use effective contraception during study and for 4 months after last dose
- Male patients must use reliable contraception or remain abstinent during study and for 4 months after last dose
- Agreement to avoid blood or sperm/oocyte donation during study and for 4 months after last dose
- Females of childbearing potential must refrain from breastfeeding during study and for 4 months after last dose
- Willingness and ability to comply with study visits and procedures
- Not currently enrolled in another clinical trial or treated with experimental drugs
You will not qualify if you...
- More than one prior line of systemic therapy
- Presence of Central Nervous System lymphoma
- Significant organ impairment including creatinine clearance ≤45 ml/min, high bilirubin, elevated liver enzymes beyond specified limits, pleural effusion, or left ventricular ejection fraction ≤45%
- Serious medical conditions limiting life expectancy to less than 3 months
- History of blood clots or high risk for thromboembolic events without willingness to take prophylaxis
- Clinically significant cardiac disease including recent unstable angina, recent heart attack, or severe heart failure
- Past or current cancers other than the lymphoma being studied, except certain localized or treated cancers in remission
- Prior autologous stem cell transplantation
- Previous treatment with anti-CD3/CD20 bispecific antibodies or tafasitamab
- Severe uncontrolled infections requiring intravenous antibiotics
- History of HIV infection or active hepatitis B or C infection unless controlled and meeting specific criteria
- Pregnancy or breastfeeding
- Richter's transformation or prior chronic lymphocytic leukemia
- Recent cancer treatments or major surgeries within 4 weeks before starting study treatment
- Recent vaccination with live vaccines or COVID-19 vaccine within 4 weeks before treatment
- History of severe allergic reactions to study drugs or similar antibodies
- Close relation or affiliation with the study investigator or site staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain, 50009
Not Yet Recruiting
2
Hospital Universitario de Burgos
Burgos, Castille and León, Spain, 09006
Not Yet Recruiting
3
ICO Badalona
Badalona, Catalonia, Spain, 08916
Not Yet Recruiting
4
Hospital Universitari Vall d'Hebrón
Barcelona, Catalonia, Spain, 08035
Not Yet Recruiting
5
Hospital San Pedro de Alcántara
Cáceres, Extremadura, Spain, 10003
Not Yet Recruiting
6
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
7
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain, 28031
Not Yet Recruiting
8
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Not Yet Recruiting
9
Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Not Yet Recruiting
10
Hospital Universitario Costa del Sol
Marbella, Málaga, Spain, 29603
Not Yet Recruiting
11
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Not Yet Recruiting
12
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain, 38320
Not Yet Recruiting
13
Hospital Universitario Dr. Peset
Valencia, Valencia, Spain, 46017
Not Yet Recruiting
14
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46024
Not Yet Recruiting
15
Hospital Universitario de Basurto
Bilbao, Vizcaya, Spain, 48013
Not Yet Recruiting
Research Team
A
Auxi Moreno
CONTACT
A
Ana María Méndez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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