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.
Additional locations may be listed on ClinicalTrials.gov for NCT05453500.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Noah Pinke
Phone: 206-606-4942
PRIMARY OBJECTIVE:
I. To examine the potential efficacy of the addition of tafasitamab (tafa) to DA-EPOCH+/-R in newly-diagnosed adults with Ph- B-ALL.
SECONDARY OBJECTIVES:
I. To describe the toxicity profile of the combination of DA-EPOCH+/-R + tafa.
II. To evaluate survival of patients after receiving DA-EPOCH+/-R + tafa for newly-diagnosed ALL.
EXPLORATORY OBJECTIVES:
I. To compare outcomes predicted by the presence of absence of minimal residual disease (MRD) as determined by either multiparameter flow cytometry (MFC) or high-throughput sequencing (HTS) via a commercially-available assay (clonoSEQ).
II. Markers of inflammatory response in blood and cerebrospinal fluid.
III. Changes in blast immunophenotype and operating characteristics of MFC after tafasitamab administration.
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. Patients undergo bone marrow aspiration or biopsy, computed tomography (CT) scan, lumbar puncture and undergo blood sample and cerebrospinal fluid collection throughout the trial.
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).
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorRyan Daniel Cassaday
