Actively Recruiting
Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL
Led by Australasian Leukaemia and Lymphoma Group · Updated on 2024-07-22
39
Participants Needed
1
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of relapsed or progressed large B-cell lymphoma or related subtypes according to WHO criteria
- Eligible for autologous stem cell transplantation based on local assessment
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Measurable disease on CT scan with corresponding positive PET scan lesions
- Tumor tissue confirmed positive for CD20 by immunohistochemistry after most recent therapy
- Adequate kidney function with creatinine clearance above 45 mL/min
- Adequate liver function: AST and ALT ≤ 3x upper limit of normal; bilirubin ≤ 1.5x upper limit or ≤ 3 if liver involvement or Gilbert's disease
- Adequate blood counts: hemoglobin ≥ 90 g/L, neutrophils ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L (or ≥ 50 x 10^9/L if marrow involved)
- Able to take oral medications
- Completed required washout periods from prior cancer treatments
- Resolved toxicities from prior therapy to acceptable levels
- If on glucocorticoids, dose tapered to ≤ 25 mg daily for 14 days before first Epcoritamab dose
- Women must be either not of childbearing potential or use highly effective birth control during and for 12 months after treatment
- Men with partners of childbearing potential must use barrier contraception during and for 12 months after treatment
- Agree not to donate eggs or sperm during and for 12 months after treatment
- Able to understand and consent to trial procedures and comply with requirements
You will not qualify if you...
- Diagnosis of primary central nervous system lymphoma
- Active secondary CNS lymphoma at screening (prior successfully treated secondary CNS lymphoma allowed without recurrence)
- Previous autologous stem cell transplant
- Other malignancies except certain early-stage or treated cancers in remission for at least 2 years
- Prior therapy with bispecific antibody targeting CD3 and CD20
- Uncontrolled systemic infection
- Known HIV infection
- Active hepatitis B or C infection
- Seizure disorder unless seizure-free for 12 months on stable therapy
- Significant cardiac disease such as recent unstable angina, myocardial infarction, heart failure grade III/IV, or low ejection fraction
- Autoimmune disease requiring permanent immunosuppressive therapy (low-dose steroids allowed for certain conditions)
- Recent live or live attenuated vaccination within 4 weeks
- Pregnant or breastfeeding women
- Any condition judged by investigator to compromise patient safety or study assessments
- Known allergy or adverse reaction to rituximab, tocilizumab, or DHAOx components
- Psychological, social, or geographic factors that would limit compliance with study protocol and follow-up requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Australasian Leukemia and Lymphoma Group
Melbourne, Victoria, Australia, 3121
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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