Study on Adding Venetoclax and/or Blinatumomab to Usual Chemotherapy for Infants with Newly Diagnosed Leukemia

Program Overview

The purpose of this study is to test if adding venetoclax and/or blinatumomab to the usual chemotherapy can be more effective in treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) that has a specific gene rearrangement (KMT2A) or not. Venetoclax works by blocking a protein that cancer cells need to survive, while blinatumomab is an antibody that may help stop cancer cells from growing and spreading. The study will evaluate the safety and effectiveness of these additional treatments in infants.

Description

The study aims to find out if adding venetoclax to the usual chemotherapy can help more infants achieve remission, meaning no signs of cancer, after the initial treatment phase. It will also compare the survival rates of infants treated with the new combination to those treated with standard chemotherapy alone. The study will look at how the body processes venetoclax and how it affects the immune system.

The treatment plan includes several phases:

• Steroid Prephase: All infants receive a steroid medication for 7 days before starting the main treatment.

• Induction Phase: Infants receive a combination of chemotherapy drugs, including venetoclax, to reduce cancer cells. If the cancer is significantly reduced, they move to the next phase.

• Blinatumomab Block 1: Infants receive blinatumomab and other supportive treatments. If the cancer is still present, they may stop the study treatment.

• Consolidation Phase: More chemotherapy is given to maintain remission. If successful, infants continue to the next phase.

• MARMA Phase: High-dose chemotherapy is administered to further eliminate cancer cells.

• Blinatumomab Block 2: Another round of blinatumomab is given.

• Delayed Intensification: Additional chemotherapy is provided to prevent cancer from returning.

• Maintenance Phase: Long-term treatment to keep the cancer from coming back, lasting up to 2 years.

Infants will undergo regular tests, including blood samples and scans, to monitor their response to treatment. After completing the study treatment, they will be followed up for up to 3 years to check their health and any long-term effects.

Eligibility Criteria

Locations