Actively Recruiting
A Trial to Assess the Safety and Efficacy of Epcoritamab-Containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma
Led by Australasian Leukaemia and Lymphoma Group · Updated on 2024-07-22
39
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of adding Epcoritamab to the salvage treatment routine for patients with relapsed or refractory aggressive B-cell lymphoma. The study aims to determine if Epcoritamab combined with intensive salvage chemotherapy is safe and improves the rate of complete remission before autologous stem-cell transplantation (ASCT). It also assesses the safety and deliverability of consolidation Epcoritamab after ASCT and whether this approach improves disease clearance and progression-free survival at 12 months compared to historical data. The treatment plan includes three phases: first, a salvage treatment combining three cycles of R-DHAOx chemotherapy (rituximab, dexamethasone, cytarabine, oxaliplatin) with weekly subcutaneous doses of Epcoritamab; second, autologous stem-cell transplantation administered locally following standard procedures; and third, a consolidation phase of six 28-day cycles of subcutaneous Epcoritamab starting 6 to 12 weeks after ASCT. The Epcoritamab dosing escalates from low priming doses to full doses during both salvage and consolidation phases. Participants will be monitored throughout the study with assessments including response rates, survival outcomes, and safety evaluations at specific time points such as before and after ASCT and during follow-up visits up to 24 months. Researchers will use imaging and clinical tests to measure disease status and treatment effects. The main outcome measured is event-free survival at 12 months, alongside other measures like overall response, complete response, overall survival, and progression-free survival.
CONDITIONS
Brief 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 progressive DLBCL, high-grade B-cell lymphoma, or follicular large B-cell lymphoma according to WHO criteria
- Eligible for autologous stem-cell transplant as assessed locally
- ECOG performance status of 0 to 2
- Measurable disease by CT scan with positive PET lesion
- Tumor confirmed CD20 positive by immunohistochemistry
- Adequate kidney function (creatinine clearance >45 mL/min)
- Adequate liver function (AST and ALT ≤3x ULN; bilirubin ≤1.5x ULN or ≤3x ULN if liver involvement)
- 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 involvement)
- Able to take oral medications
- At least 4 weeks since last immunochemotherapy or other anti-cancer therapy; at least 6 weeks since CAR-T therapy
- Toxicities from prior therapy resolved to acceptable levels
- If on glucocorticoids, tapered to ≤25 mg daily in last 14 days before first Epcoritamab dose
- Women must be not of childbearing potential or using effective birth control; men must use barrier contraception during and 12 months after treatment
- Consent and ability to comply with study requirements
You will not qualify if you...
- Diagnosis of primary central nervous system lymphoma
- Active secondary CNS lymphoma at screening
- Prior autologous stem-cell transplant
- Other malignancies except certain low-risk or treated cancers
- Previous treatment with bispecific antibody targeting CD3 and CD20
- Uncontrolled systemic infection
- Known HIV infection
- Active hepatitis B or C infection
- Uncontrolled seizure disorder needing recent medication changes
- Significant heart disease including recent unstable angina or heart failure
- Autoimmune disease requiring permanent immunosuppressive therapy (except low-dose steroids)
- Live vaccine within 4 weeks before enrollment
- Pregnant or breastfeeding women
- Conditions that may interfere with study compliance or assessments
- Known allergies to rituximab, tocilizumab, or DHAOx components
- Psychological, social, or geographic factors limiting study participation or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 9 months (including salvage therapy, ASCT, and consolidation)
Participants receive Epcoritamab combined with 2-3 cycles of R-DHAOx chemotherapy every 21 days, followed by autologous stem cell transplantation (ASCT), then 6 cycles of Epcoritamab consolidation over 28-day cycles starting 6-12 weeks after ASCT.
Weekly visits during salvage therapy, then visits every 1 to 2 weeks during consolidation
Duration - Up to 24 months after treatment completion
Participants are monitored for safety, disease response, and survival outcomes with ongoing assessments up to 24 months from registration.
Visits every 3 months during follow-up
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here