Clinical Trial ID: NCT03926624
Phase III Randomized Trial of DFP-10917 vs. Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine) or Intensive Reinduction (High and termediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second or Third Salvage
This is a Phase III, multicenter, randomized, controlled study to compare the rate of CR and duration of CR, in patients with relapsed or refractory AML to a prior intensive chemotherapy regimen (e.g., "7+3" cytarabine and daunorubicin) or to an epigenetic therapy (i.e., azacitidine or decitabine), who will receive DFP-10917 versus LoDAC or azacitidine as a first-salvage treatment.
The primary objective is to compare the rate of Complete Remission (CR) and duration of CR, in patients who receive DFP-10917 versus non-intensive reinduction (LoDAC, azacitidine, decitabine) or intensive reinduction (high and intermediate dose cytarabine regimens) as second or third salvage treatment.
Experimental Arm; DFP-10917
14-day continuous intravenous (IV) infusion at a dose of 6 mg/m2/day followed by a 14-day resting period per 28-day cycles. If a patient experiences a significant treatment-related adverse event (AE), the patient may undergo one dose reduction of DFP-10917 to 4 mg/m2/day x 14 days for subsequent treatment cycles.
Active Comparator: LoDAC or Azacitidine
• LoDAC: Cytarabine at 20 mg administered subcutaneously (SC) twice daily (BID) for 10 days, plus best supportive care per 28-day treatment cycle.
• Azacitidine: 75 mg/m2/day administered SC for 7 days, plus best supportive care per 28-day treatment cycle.
Baptist MD Anderson Cancer Center
- Histologically or pathologically confirmed diagnosis of AML based on WHO classification that has relapsed after, or is refractory to, a prior intensive chemotherapy regimen (e.g., "7+3" cytarabine and daunorubicin) or epigenetic therapy (i.e., azacitidine or decitabine).
- Aged > 18 years.
- ECOG Performance Status of 0, 1 or 2.
- 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).
- Absence of active central nervous system (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.
- Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
- Signed 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.
- The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and is to be discontinued prior to randomization.
- Patients with first leukemia remission >24 months.
- Prior leukemia salvage therapy following relapsed disease or following failed first induction.
- Suitable for and willing to receive intensive re-induction chemotherapy (e.g., "7+3", MEC, FLAG, HiDAC).
- Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
- Cardiac (left ventricular ejection fraction < 40%) function.
- White blood cell (WBC) count >15,000/uL.
- Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
- A pregnant or lactating woman.
- Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
- Patient has acute promyelocytic leukemia (APL).
- Patients with known HIV, HBV or HCV infection (note: testing for these infections is not required).
- Documented or known clinically significant bleeding disorder.
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