drugset / Trial / NCT05453500

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

NCT05453500

Phase 2 Active not recruiting 32 enrolled University of Washington Incyte Corporation · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab \[DA-EPOCH+/-R\]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.

Timeline

Start
2023-03-27
Primary completion
2026-04-28
Completion
2031-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tafasitamab Monoclonal antibody Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Prednisone Other / unclassified Oral
Background Rituximab Monoclonal antibody Intravenous
Background Vincristine Small molecule Intravenous