OncoMatch/Clinical Trials/NCT06287398
Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL
Is NCT06287398 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Epcoritamab for dlbcl - diffuse large b cell lymphoma.
Treatment: Epcoritamab — The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are: * Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant? * Is consolidation epcoritamab after ASCT deliverable and safe? * Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease? * Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population. Participants will undergo three phases in this trial: 1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab 2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures. 3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 overexpression
Histological confirmation of tumour CD20 positivity, analysed by immunohistochemistry, on a pre-enrolment tissue sample performed after most recent prior therapy
Allowed: MYC rearrangement
DLBCL/HGBL with MYC and BCL2 rearrangements
Allowed: BCL2 rearrangement
DLBCL/HGBL with MYC and BCL2 rearrangements
Allowed: BCL6 rearrangement
DLBCL/HGBL with MYC and BCL6 rearrangements
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemoimmunotherapy
relapsed or progressed after one line of chemoimmunotherapy
Cannot have received: autologous stem cell transplant
Prior autologous stem cell transplant
Cannot have received: bispecific antibody targeting CD3 and CD20
Any prior therapy with a bispecific antibody targeting CD3 and CD20
Lab requirements
Blood counts
Haemoglobin >= 90g/L (transfusion support permitted); ANC >= 1.0 x 10^9/L (growth factor support allowed in case of bone marrow involvement); Platelet count > 75 x 10^9/L or >= 50 x 10^9/L if documented marrow involvement
Kidney function
Creatinine clearance > 45 mL/min (Cockcroft Gault formula)
Liver function
AST and ALT <= 3x ULN; Bilirubin <= 1.5x ULN or <= 3x ULN if documented liver involvement and/or Gilbert's disease
Cardiac function
No clinically significant cardiac disease, including: unstable angina pectoris or acute myocardial infarction within 6 months, congestive heart failure (NYHA III or IV), ejection fraction < 45%
Adequate renal function: Creatinine clearance > 45mL/min (Cockcroft Gault formula); Adequate hepatic function: AST and ALT <= 3x ULN; Bilirubin <= 1.5x ULN or <= 3x ULN if documented liver involvement and/or Gilbert's disease; Adequate haematologic function: Haemoglobin >= 90g/L (transfusion support permitted); ANC >= 1.0 x 10^9/L (growth factor support allowed in case of bone marrow involvement); Platelet count > 75 x 10^9/L or >= 50 x 10^9/L if documented marrow involvement; No clinically significant cardiac disease, including: unstable angina pectoris or acute myocardial infarction within 6 months, congestive heart failure (NYHA III or IV), ejection fraction < 45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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