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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 (Jun 2026). This Phase 2 trial studies Epcoritamab for dlbcl - diffuse large b cell lymphoma.

Phase 2RecruitingAustralasian Leukaemia and Lymphoma GroupNCT06287398Data as of Jun 2026Location: Australia

Treatment: EpcoritamabThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Epcoritamab

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

Min 1 prior line

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.

Frequently asked questions

Is NCT06287398 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior autologous stem cell transplant, bispecific antibody targeting CD3 and CD20 disqualifies patients from enrollment.

Does this trial require CD20?

Yes, CD20 overexpression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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