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Tests treatment safety and results for Large B Cell Lymphoma
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
ClinicalTrials.gov ID: NCT07126236
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, being studied as a potential treatment for large b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent must be obtained before any study-specific assessment is performed.
- Age \>18 years
- Patients with Relapse/Refractory histologically confirmed LBCL, including, Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell...
- PD as best response to first line therapy.
- SD as best response after at least 4 cycles of first line therapy.
You likely can't join if
- Patients who received more than one prior line of systemic therapy
- Patients with detectable Central Nervous System (CNS) lymphoma
- Significant organ function impairment:
- creatinine clearance calculated by Cockcroft-Gault ≤ 45 ml/min
- direct bilirubin level \< 2 x ULN (except in patients with Gilbert's syndrome),
- alanine transaminase (ALT) and aspartate aminotransferase (AST) \>3 × ULN or \>5 × ULN in cases of documented liver involvement.
See the full eligibility criteria
Who can join
- Written informed consent must be obtained before any study-specific assessment is performed.
- Age \>18 years
- Patients with Relapse/Refractory histologically confirmed LBCL, including, Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell Lymphoma (PMBCL), High-grade B-cell lymphoma (HGBCL); and grade 3B...
- PD as best response to first line therapy.
- SD as best response after at least 4 cycles of first line therapy.
- PR as best response after at least 6 cycles of first line therapy.
- CR and disease recurrence within \< 6 months from the completion of first-line therapy.
- Patients must have received adequate first-line therapy including at a minimum: an anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and CHOP (cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone) or...
- At the investigator's discretion, the patient should not be a candidate for 1st relapse CAR-T therapy or unwilling to receive CAR-T therapy.
- Patients must be autologous stem cell transplantation (ASCT)-ineligible: Age ≥65 and/or HTC-CI ≥3 or or unwilling to receive transplant.
- PET positive disease.
- Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2.
- Patients meeting with the following hematology values:
- Hemoglobin ≥8 g/dl (transfusion support permitted but not within 7 days of screening lab collection)
- Absolute neutrophil count (ANC) ≥ 1/109/L (growth factor support allowed in case of bone marrow involvement).
- Absolute lymphocyte count ≥ 0.1/109/L,
- Platelet count ≥ 70/109/L (unless secondary to bone marrow involvement, OR ≥50x/109/L if documented bone marrow involvement). Platelet transfusions permitted but not within 7 days of screening lab collection.
- Female patients of child-bearing potential must have a negative urine or serum pregnancy test at screening and agree to use highly effective methods of contraception (e.g., established use of oral, injected or implanted...
- Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrollment according to the recommendations provided by CTFG, during the treatment period, and...
- Women must agree not to donate blood or oocytes during the course of the study and for 4 months after the last dose of study medication. Restrictions concerning blood donation apply as well to females who are not of...
- Females of childbearing potential must refrain from breastfeeding during the course of the study and for 4 months after the last dose of study medication.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Not included in other clinical trial or treated with an experimental drug.
What rules you out
- Patients who received more than one prior line of systemic therapy
- Patients with detectable Central Nervous System (CNS) lymphoma
- Significant organ function impairment:
- creatinine clearance calculated by Cockcroft-Gault ≤ 45 ml/min
- direct bilirubin level \< 2 x ULN (except in patients with Gilbert's syndrome),
- alanine transaminase (ALT) and aspartate aminotransferase (AST) \>3 × ULN or \>5 × ULN in cases of documented liver involvement.
- clinically relevant pleural effusion,
- left ventricular ejection fraction (LVEF) ≤ 45%
- Serious accompanying disorder leading to impaired organ function causing significant clinical problems and reduced life expectancy of less than 3 months.
- Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to...
- Known clinically significant cardiac disease, including:
- Onset of unstable angina pectoris within 6 months of signing the patient informed consent form.
- Acute myocardial infarction within 6 months of signing the patient informed consent form.
- Congestive heart failure (grade III or IV as classified by the New York Heart Association.
- Left ventricular ejection fraction ≤45%.
- Known past or current malignancy other than inclusion diagnosis, except for: Cervical carcinoma of Stage 1B or less; Non-invasive basal cell or squamous cell skin carcinoma; Non-invasive, superficial bladder cancer...
- Previous ASCT.
- Prior anti-CD3 and CD20 bispecific antibodies therapy or prior treatment with tafasitamab.
- Presence of severe infection that is uncontrolled or requiring IV antimicrobials for management.
- History of HIV infection or acute or chronic active hepatitis B or C infection.
- Individuals with positive HIV serology may be included if negative viral load and CD4 \>200/mm3. For being included, patients should have controlled disease and been on treatment for at least 1 year
- Individuals with history of hepatitis infection with positive antibodies (anti-HB and anti-HV) might be included if negative viral load (negative hepatitis B PCR). Patients who are HBcAb positive must receive HBV...
- Females who are pregnant or breastfeeding.
- Richter's transformation or prior chronic lymphocytic leukemia (CLL).
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 4 weeks prior to Cycle 1 Day 1.
- Recent major surgery (within 4 weeks before the start of Cycle 1 Day 1) other than for diagnosis.
- Vaccination with a live vaccine or COVID-19 vaccination within 4 weeks prior to treatment.
- History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal...
- Close affiliation with the investigator (e.g. a close relative) or persons working at the study site.
The study team makes the final eligibility decision.
Where it's taking place
- Zaragoza, Aragon, Spain
- Burgos, Castille and León, Spain
- Badalona, Catalonia, Spain
- Barcelona, Catalonia, Spain
- Cáceres, Extremadura, Spain
- Madrid, Madrid, Spain
- El Palmar, Murcia, Spain
- Marbella, Málaga, Spain
- Oviedo, Principality of Asturias, Spain
- San Cristóbal de La Laguna, Tenerife, Spain
- Valencia, Valencia, Spain
- Bilbao, Vizcaya, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zaragoza, Aragon, Spain; Burgos, Castille and León, Spain; Badalona, Catalonia, Spain; Barcelona, Catalonia, Spain; Cáceres, Extremadura, Spain; Madrid, Madrid, Spain and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.