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D18-11141 Phase III Randomized Trial of DFP-10917 vs. Non-Intensive Reinduction (LoDAC, Azacitidine Decitabine, Venetoclax combination regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patie

NCT03926624

Phase III Randomized Trial of DFP-10917 vs. Non-Intensive Reinduction (LoDAC, Azacitidine Decitabine, Venetoclax combination regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth Salvage.

Associated Conditions

Leukemia

Principal Investigator

Sponsor

Delta-Fly Pharma

This study will investigate whether a new experimental treatment, DFP-10917, will be an effective and safe treatment option for patients with relapsed/refractory acute myelogenous leukemia (AML). The purpose of this study is to compare the safety and effectiveness of DFP-10917 versus available treatments that are considered Standard of Care (SOC) for patients who have not responded to previous chemotherapy treatments (refractory AML) or have relapsed following remission with prior treatment (relapsed AML). Patients with a history of high or very high-risk Myelodysplastic Syndrome (MDS), myeloproliferative neoplasms (MPN), or high-risk primary myelofibrosis (PMF) that transformed to AML during treatment with previous chemotherapy may also be included. SOC includes non-intensive reinduction (low-dose cytarabine (LodDAC), azacitidine, decitabine, venetoclax + LoDAC or azacitidine or decitabine), or intensive reinduction (high and intermediate dose cytarabine regimens) as a treatment.

This study is currently enrolling.