OncoMatch/Clinical Trials/NCT05453500
Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia
Is NCT05453500 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for b acute lymphoblastic leukemia, philadelphia chromosome negative.
Treatment: Cyclophosphamide · Doxorubicin · Etoposide · Prednisone · Rituximab · Tafasitamab · Vincristine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (CD19+)
newly-diagnosed CD19+ Ph- B-ALL
Required: BCR wild-type
Philadelphia chromosome negative
Required: ABL1 wild-type
Philadelphia chromosome negative
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: to control acute symptoms and/or hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.)
No prior systemic therapy for ALL except to control acute symptoms and/or hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.)
Lab requirements
Kidney function
Calculated creatinine clearance > 30 ml/min (MDRD equation)
Liver function
Total bilirubin ≤ 2.0 x ULN (≤ 4.0 x ULN if Gilbert's or inherited indirect hyperbilirubinemia); AST/ALT ≤ 5.0 x ULN (≤ 8.0 x ULN if hepatic involvement by ALL); total bilirubin ≤ 5.0 x ULN and ALT/AST ≤ 8.0 x ULN if hepatic involvement by ALL
Total bilirubin ≤ 2.0 x ULN (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be ≤ 4.0 x ULN); AST/ALT ≤ 5.0 x ULN. (Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and ALT/AST are ≤ 8.0 x ULN); Calculated creatinine clearance of > 30 ml/min, as measured by the MDRD equation, will be eligible; As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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