Study Comparing Blinatumomab Alone to Blinatumomab with Nivolumab in Patients with First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Program Overview

This clinical trial is testing if combining two drugs, blinatumomab and nivolumab, is more effective than using blinatumomab alone in treating patients whose B-cell acute lymphoblastic leukemia (B-ALL) has come back after treatment. Blinatumomab is a type of antibody that targets cancer cells, while nivolumab may help boost the immune system. The study aims to see if this combination can stop the cancer from growing and reduce symptoms like pain.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse when treated with either blinatumomab alone or with the addition of nivolumab. This is being tested in patients aged 1 to under 31 years old who have had their first relapse of B-ALL. The study also looks at the safety and side effects of the combination treatment.

The study includes different groups based on age, type of relapse, and whether the patient has Down syndrome. Patients are assigned to different treatment groups based on these factors. Some patients will receive blinatumomab alone, while others will receive both blinatumomab and nivolumab.

Patients will undergo various treatments, including chemotherapy and immunotherapy, and will be monitored for side effects and how well the treatment is working. The study will also collect information on how the cancer responds to treatment and any changes in the patient's health.

After completing the study treatment, patients will have follow-up visits every three months for one year to monitor their health and any changes in their condition.

Eligibility Criteria

Locations