drugset / Trial / NCT06124157

A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

NCT06124157

Phase 2 Recruiting 222 enrolled National Cancer Institute (NCI)
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.

Timeline

Start
2025-05-30
Primary completion
2030-12-01
Completion
2030-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody Intravenous
Subject Imatinib Small molecule Oral
Subject dasatinib anhydrous Small molecule Oral
Background Calaspargase Pegol Protein / enzyme biologic Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Leucovorin Small molecule Oral
Background MERCAPTOPURINE ANHYDROUS Small molecule Oral
Background Methotrexate Small molecule Intrathecal
Background Pegaspargase Protein / enzyme biologic Intravenous
Background Prednisolone Other / unclassified Oral
Background Prednisone Other / unclassified Oral
Background Thioguanine Small molecule Oral
Background Vincristine Small molecule Intravenous