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

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Clinical Trial

Official title: Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) +/- Rituximab (R) + Tafasitamab-cxix for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative (Ph-) B-cell Lymphoblastic Lymphoma/Leukemia (B-ALL)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

OUTLINE:

Patients receive etoposide, doxorubicin, and vincristine intravenously (IV) continuously over 96 hours on days 1-4 of each cycle, cyclophosphamide IV over 1 hour on day 5 of each cycle, prednisone orally (PO) twice daily (BID) on days 1-5 of each cycle, and tafasitamab IV weekly on days 1, 8, and 15 of each cycle. CD20 positive patients also receive rituximab IV per guidelines on days 1 or 5 of each cycle. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and every 6 months for 3 years (total follow-up time 5 years). ;

Related Conditions & MeSH terms

• B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT05453500
• Study type: Interventional
• Source: University of Washington
• Contact: Allie Rasmussen
• Phone: 206-606-2446
• Email: allegr@uw.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 27, 2023
• Completion date: September 1, 2030