None listed
Conditions
Brief summary
Follicular lymphoma (FL) is a common type of slow-growing blood cancer. In Australia, the standard treatment for FL is a combination of drugs and immunotherapy. However, this treatment can have side effects, and the cancer can come back without clear options for further treatment. Researchers are now focusing on finding better options to treat FL with fewer side effects and better outcomes for patients. Who is it for? You may be eligible for this study if you are aged 18 and have been diagnosed with follicular lymphoma. Study details LS25 will operate as a sub-study of an AbbVie-sponsored clinical trial called EPCORE-FL2, with the aim to closely monitor how the immune system responds to treatment for FL over time. EPCORE-FL2 patients can choose to participate in LS25, where they will provide extra blood samples, biopsy sample and collect gastrointestinal microbiota sampling. These samples will help researchers understand how the immune system is working inside the tumor and in the bloodstream during treatment. The hope is that by studying these samples, treatments can be tailored more effectively for people with FL, potentially leading to better outcomes.
Interventions
Follicular lymphoma (FL) is a common type of slow-growing blood cancer. In Australia, the standard treatment for FL is a combination of drugs and immunotherapy. However, this treatment can have side effects, and the cancer can come back without clear options for further treatment.
The LS25 trial is a translational sub-study to the upcoming EPCORE-FL2 trial sponsored by AbbVie. Patients enrolled to the EPCORE-FL2 trial will be recruited to the LS25 trial and will be consented for 1) the collect
Follicular lymphoma (FL) is a common type of slow-growing blood cancer. In Australia, the standard treatment for FL is a combination of drugs and immunotherapy. However, this treatment can have side effects, and the cancer can come back without clear options for further treatment. The LS25 trial is a translational sub-study to the upcoming EPCORE-FL2 trial sponsored by AbbVie. Patients enrolled to the EPCORE-FL2 trial will be recruited to the LS25 trial and will be consented for 1) the collection of an additional volume of peripheral blood at 5 timepoints 2) self-administration of gastrointestinal microbiota sampling and 3) an ‘on-treatment’ biopsy. All collection timepoints for the ALLG LS25 trial correspond to those in the EPCORE FL-2 clinical trial at: 1. baseline 2. cycle 1 day 15 3. on-treatment biopsy window between cycle 1 day 8 – cycle 2 day 1 4. 24 weeks 5. 120 weeks. There are no additional collection timepoints outside of the clinical trial protocol.
Sponsors
Australasian Leukaemia and Lymphoma Group (ALLG)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients at who are participating in the Abbvie sponsored clinical trial titled ‘A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab and Rituximab and Lenalidomide (R2) compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE FL-2)’ are eligible to partake in the ALLG LS25 study. 1. Diagnosis of follicular lymphoma (FL). 2. Have CD20, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours. 3. Must have stage, III or IV disease, or stage II with bulky disease (tumor diameter of greater than or equal to 7 cm). 4. Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria. 5. Has one or more target lesions: a) A positron emission tomography (PET) or computerized tomography (CT) scan demonstrating PET-positive lesion(s), and b) Have greater than or equal to 1 measurable nodal lesion (long axis greater than 1.5cm) or greater than or equal to 1 measurable extra-nodal lesion (long axis greater than 1.0 cm) on CT scan or MRI 6) Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 7) Eligible to receive one of the standard of care regimens: chemoimmunotherapy (CIT) or rituximab and lenalidomide (R2). 8) Have laboratory values meeting the criteria in the protocol.
Exclusion criteria
1) Had major surgery within 4 weeks prior to randomization. 2) Have active cytomegalovirus (CMV) disease..
Outcome results
None listed