#1 Clinical Trials Search in Europe

Human Immunoglobulin G

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.

Table of Contents

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.[1]

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.[1]

Who can join the study

The trial is for patients aged 0 to 18 years.[1]

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.[1]

The study also includes patients with isolated extramedullary disease, which means the disease is found outside the bone marrow.[1]

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.[1]

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.[1]

Study phase and size

This is a Phase 2 trial.[1]

Phase 2 studies usually focus on whether a treatment works in a specific group of patients, while also continuing to collect important clinical information.[1]

The planned enrollment is 33 participants.[1]

Main endpoints

The primary outcome is the complete response rate, which includes complete remission and complete remission with incomplete haematological recovery.[1]

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.[1]

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.[1]

Patient-focused terms

Complete remission means the signs of leukemia are no longer seen on testing.[1]

Incomplete haematological recovery means the leukemia is gone, but blood counts have not fully returned to normal.[1]

Measurable residual disease refers to tiny amounts of cancer that may still be present after treatment and can only be found with sensitive tests.[1]

Cerebrospinal fluid is the fluid around the brain and spinal cord, and it may be tested when the disease is outside the bone marrow.[1]

Trial ID Phase Condition studied Status Enrollment
2024-515467-66-00 Phase 2 Acute lymphoblastic leukemia Authorised 33

FAQ

  • What is being studied in the Human Immunoglobulin G trial? The trial is studying treatment response in children and adolescents with CD19+ acute lymphoblastic leukemia that is resistant or refractory to treatment. It measures how many patients achieve a complete response after the infusion.
  • Who can take part in this trial? The study is for children and adolescents aged 0 to 18 years with CD19+ acute lymphoblastic leukemia that has not responded well to treatment. The trial also includes patients with isolated extramedullary disease, which means disease outside the bone marrow.
  • What phase is the trial? This is a Phase 2 trial. Phase 2 studies mainly look at whether a treatment works and continue to collect safety information.
  • What outcome is the trial measuring? The main outcome is complete response rate, including complete remission and complete remission with incomplete blood recovery. The study also checks for no detectable measurable residual disease by a special lab test.
  • How many people are planned for this study? The planned enrollment is 33 participants. This means the researchers expect to include 33 patients in the study.

Ongoing Clinical Trials on Human Immunoglobulin G

  • Study of ARI-0001 Cells for Children and Adolescents with Resistant or Refractory Acute Lymphoblastic Leukemia

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Acute lymphoblastic leukemia: A fast-growing cancer of the blood and bone marrow that affects white blood cells.
  • CD19+: A marker found on the surface of certain leukemia cells. It helps identify the type of cells the study is targeting.
  • Resistant or refractory: This means the disease does not respond well to treatment, or it comes back after treatment.
  • Interventional study: A clinical trial where researchers give a treatment and then measure the results.
  • Phase 2: A trial stage that mainly looks at whether a treatment works in a specific group of patients.
  • Complete response: A major treatment result where signs of the disease are no longer seen.
  • Complete remission with incomplete haematological recovery: A strong response where the leukemia is not seen, but blood counts have not fully returned to normal.
  • Measurable residual disease: Very small amounts of cancer that may remain after treatment and can be found with sensitive tests.
  • Multiparameter flow cytometry: A lab test that looks for tiny numbers of leukemia cells by checking several cell markers at once.
  • Extramedullary disease: Disease found outside the bone marrow, such as in other body tissues.

References

  1. https://clinicaltrials.gov/study/2024-515467-66-00