Study on Blinatumomab for Treating Young Patients with Relapsed B-cell Acute Lymphoblastic Leukemia

Program Overview

The purpose of this study is to determine if blinatumomab, an immunotherapy drug, is more effective than standard chemotherapy in treating young patients with B-cell acute lymphoblastic leukemia (B-ALL) that has relapsed. Blinatumomab may help the immune system target and destroy leukemia cells. The study will compare how well patients do with blinatumomab versus traditional chemotherapy in terms of survival and disease control.

Description

This study involves several treatment phases for young patients with relapsed B-cell acute lymphoblastic leukemia (B-ALL). Initially, all patients receive a first round of chemotherapy (Block 1) to prepare for further treatment. After this, patients are divided into different groups based on their risk level and are randomly assigned to receive either additional chemotherapy or blinatumomab.

For high-risk and intermediate-risk patients, the study compares two options: continuing with intensive chemotherapy or switching to blinatumomab treatment. For low-risk patients, the study compares chemotherapy alone to chemotherapy combined with blinatumomab.

The study aims to see which treatment option leads to better outcomes, such as longer survival without the disease returning and overall survival rates. It also looks at how well the treatments reduce the amount of leukemia cells left in the body and the safety of the treatments.

Patients will receive various medications during the study, including dexamethasone, vincristine, pegaspargase, and methotrexate, among others. Some patients may also receive radiation therapy if needed. The study includes regular follow-ups to monitor patients' health and the effectiveness of the treatment over time.

Eligibility Criteria

Locations