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

Study 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.

Primary Outcome

Efficacy of the addition of tafasitamab (tafa) to dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin with our without rituximab (DA-EPOCH±R) will be assessed using the rate of minimal residual disease (MRD) as measured by multiparameter flow cytometry (MFC) in the University of Washington hematopathology lab. Will consider an absolute increase in the rate of MRD- after one cycle to 50% to be a signal of interest (i.e., increase from 28%).

Conditions Studied

Interventions

• DRUG Cyclophosphamide
• DRUG Doxorubicin
• DRUG Etoposide
• DRUG Prednisone
• BIOLOGICAL Rituximab

Study Locations (1)