Active — Not RecruitingPhase 2

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

United States32 participantsStarted 2023-03-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (age 18 years and older) with newly-diagnosed CD19+ Ph- B-ALL * In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., \>= 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen * Marrow or blood involvement detectable by MFC * Total bilirubin =\< 2.0 x upper limit of normal (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) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5.0 x institutional ULN. (Note: 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 Modification of Diet in Renal Disease (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 * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performan…

What they're measuring

Rate of minimal residual disease (MRD)

Timeframe: After 1 cycle of treatment (each cycle = 21 days)

Trial details

NCT IDNCT05453500

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-28