In short
Clinical trials investigating Human Immunoglobulin G are studying its use as part of treatment in children and adolescents with resistant or refractory CD19+ acute lymphoblastic leukemia. These trials aim to evaluate treatment response and other outcomes in an interventional Phase 2 study. The focus is on how well the study treatment works in this patient group.
Key points
- Clinical trials investigating Human Immunoglobulin G are being used in a Phase 2 study for children and adolescents with resistant or refractory CD19+ acute lymphoblastic leukemia. The trial is interventional and plans to enroll 33 participants. Researchers are mainly looking at complete response and measurable residual disease after treatment. The study also includes patients with isolated extramedullary disease. This trial is focused on whether the treatment approach can help patients whose leukemia has not responded well before.
Trial overview
This authorised interventional study is a Phase 2 trial in children and adolescents with CD19+ acute lymphoblastic leukemia that is resistant or refractory to treatment.
The brief summary says the study is designed to evaluate the efficacy, meaning how well the treatment works, in paediatric patients with this type of leukemia.
Who can join the study
The trial is for patients aged 0 to 18 years.
It includes children and adolescents with CD19+ acute lymphoblastic leukemia that is resistant or refractory, which means the disease has not responded well to prior treatment.
The study also includes patients with isolated extramedullary disease, which means the disease is found outside the bone marrow.
What is being tested
The trial title lists several medicines used around the infusion, including etoposide, methylprednisolone, cytarabine, dexchlorpheniramine maleate, paracetamol, cyclophosphamide, allopurinol, tocilizumab, Human Immunoglobulin G, varnimcabtagene autoleucel, and fludarabine.
The main study treatment named in the title is varnimcabtagene autoleucel, while Human Immunoglobulin G appears in the intervention list as one of the drugs used in the trial.
Study phase and size
This is a Phase 2 trial.
Phase 2 studies usually focus on whether a treatment works in a specific group of patients, while also continuing to collect important clinical information.
The planned enrollment is 33 participants.
Main endpoints
The primary outcome is the complete response rate, which includes complete remission and complete remission with incomplete haematological recovery.
The study also measures whether patients have undetectable measurable residual disease by multiparameter flow cytometry within day +100 after the infusion of ARI-0001 cells.
For patients with isolated extramedullary disease, response is checked with morphology and flow cytometry of the cerebrospinal fluid and/or imaging tests such as PET-CT or MRI.
Patient-focused terms
Complete remission means the signs of leukemia are no longer seen on testing.
Incomplete haematological recovery means the leukemia is gone, but blood counts have not fully returned to normal.
Measurable residual disease refers to tiny amounts of cancer that may still be present after treatment and can only be found with sensitive tests.
Cerebrospinal fluid is the fluid around the brain and spinal cord, and it may be tested when the disease is outside the bone marrow.