Clinical Trial TitlePhase 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 AML patients in 2nd, 3rd or 4th salvage.
National Clinical Trial Number:NCT03926624
Clinical Trial Protocol Description:
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 your type of cancer (acute myelogenous leukemia or AML).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a histologically or pathologically confirmed diagnosis of AML based on WHO classification that has relapsed after, or is refractory to, two or three prior induction regimens that may have included intensive chemotherapy (e.g., “7+3” cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine), or targeted therapy (e.g., FLT-3, IDH-1/2, BCL-2, monoclonal antibody).
- Relapse is defined as reemergence of ≥5% leukemia blasts in bone marrow or ≥1% blasts in peripheral blood 90 days to 24 months after first CR or CR without complete platelet recovery (CRp).
- Refractory AML is defined as persistent disease ≥28 days after initiation of intensive induction therapy (up to two induction cycles) or relapse <90 days after first CR or CRp.
- Refractory disease for patients undergoing hypomethylating agent induction is defined as lack of remission following at least 2 cycles of epigenetic therapy without reduction in bone marrow blast status.
- Are at least 18 years of age.
- Have an ECOG Performance Status of 0, 1 or 2.
- Have adequate clinical laboratory values (i.e., plasma creatinine < 2.5 x upper limit of normal (ULN) for the institution, bilirubin < 2.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN).
- Have an absence of active CNS involvement by leukemia. Patients with previously diagnosed CNS leukemia are eligible if the CNS leukemia is under control and intrathecal treatment may continue throughout the study.
- Have an absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
- Sign an informed consent prior to the start of any study specific procedures.
- Women of child-bearing potential must have a negative serum or urine pregnancy test.
- Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.