RecruitingPhase 2ACTRN12625000387426

CLL11 - A study to evaluate the efficacy of Epcoritamab consolidation in high genomic risk and Measurable Residual Disease (MRD)-positive Chronic Lymphocytic Leukaemia (CLL) patients after first-line venetoclax and obinutuzumab

CLL11 - An ALLG phase II trial of Epcoritamab consolidation in high genomic risk and MRD-positive Chronic Lymphocytic Leukaemia (CLL) patients after first-line venetoclax and obinutuzumab

Sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Enrollment

38 participants

Start Date

Dec 31, 2025

Study Type

Interventional

Conditions

Chronic Lymphocytic Leukaemia

Summary

The purpose of this study is to evaluate if treatment with epcoritamab will improve outcomes compared with historical value through increased conversion to U-MRD4 (cohort 1) and reduced loss of U-MRD4 (cohort 2) for patients diagnosed with CLL. Who is it for? You may be eligible for this study if you are aged 18 and above and have been diagnosed with CLL or SLL Study details This is a multi-centre single arm non-randomised phase II study in 2 distinct cohorts of patients: Cohort 1: Patients that are MRD4+ (defined as >10-4 on peripheral blood samples) at 3 months after completion of Ven-Obin, irrespective of pre-treatment genomics. Cohort 2: Patients with CLL with adverse-risk genomics (defined as TP53 aberrancy and/or unmutated IGHV) detected before treatment and achieving undetectable MRD4 (U-MRD4) at 3 months following completion of Ven-Obin induction. Both cohorts will receive the following treatment: - Epcoritamab will be administered as a subcutaneous injection on a 28-day cycle. In Cycle 1 epcoritamab will be administered on days 1, 8, 15 and 22, following the ramp-up schedule. - From cycle 2 onwards, epcoritamab will be administered on day 1 of each cycle. During treatment, patients will have the following assessments : · Haematology: Haemoglobin, WBC, Platelets · Biochemistry: Urea, creatinine and electrolytes · Assess AEs A total of 38 patients is planned, 14 in cohort 1 and 24 in cohort 2. Each patient will be followed for 4 years post completion of trial treatment, unless withdrawn previously. The total trial duration is expected to be 7 years. All treatment will be administered by the study team. Drug accountability will be performed by the administering institutions to assess compliance. It is hoped this research will determine if Epcoritamab treatment can improve outcomes for patients diagnosed with CLL.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic lymphocytic leukaemia (CLL) is a blood cancer where the body produces too many abnormal white blood cells. A common first-line treatment called Ven-Obi (venetoclax plus obinutuzumab) is very effective, but some patients either still have detectable cancer cells in their blood after treatment ends, or they have genetic features of the cancer that suggest a high risk of it coming back. This Phase 2 study tests whether adding epcoritamab — a newer antibody-based treatment — after Ven-Obi can eliminate remaining disease or reduce the risk of relapse. Epcoritamab is given as a subcutaneous injection on a 28-day cycle. Two groups of patients will be enrolled: those with detectable residual cancer cells after Ven-Obi (Cohort 1), and those who achieved undetectable disease but have high-risk genetic features (Cohort 2). All participants will be followed for up to four years after completing treatment. You may be eligible if you are 18 or older, have a diagnosis of CLL or SLL, have completed 12 months of first-line Ven-Obi therapy, and fall into one of the two cohort categories above. You must have adequate organ function and a good performance status. People who have received any prior treatment for CLL other than Ven-Obi are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Epcoritamab is supplied as a concentrate for solution for intended subcutaneous injection. Epcoritamab will be provided by AbbVie as 4mg/0.8mL and 48mg/0.8mL vials. As per standard of care (SOC) pr

Epcoritamab is supplied as a concentrate for solution for intended subcutaneous injection. Epcoritamab will be provided by AbbVie as 4mg/0.8mL and 48mg/0.8mL vials. As per standard of care (SOC) practices, patients will receive induction therapy of 12 cycles with venetoclax and obinutuzumab (Ven-Obi) as directed by their care provider. Eligible patients will be registered to the CLL11 trial prior to an Measurable Residual Disease (MRD) assessment, which will be performed 12-24 weeks post-completion of Ven-O. For clarity, Ven-Obi treatment is available as SOC and is not a part of the CLL11 Moonshot Trial treatment schedule. Epcoritamab will be administered as a subcutaneous injection on a 28-day cycle. In Cycle 1 epcoritamab will be administered on day 1 (0.16 mg), day 8 (0.8 mg), day 15 (3.0 mg) and 22 (48mg) as a standard dose-escalation cycle, From cycle 2 onwards, epcoritamab will be administered on day 1 of every cycle at a fixed dose of 48mg for 11 cycles after (until cycle 12). Both patient cohorts will be given the same treatment and all treatment will be administered by the study team. Drug accountability will be performed by the administering institutions to assess compliance. The approximate duration of study participation for patients is a maximum of 5 years (1 year treatment, 4 years follow up)

Locations(1)

New Zealand

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