D18-11141 Phase 3 Randomized Trial Of Dfp-10917 Vs Non-Intensive Reinduction (Lodac, Azacitidine, Decitabine, Venetoclax Combination Regimens) Or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) For Acute Myelogenous Leukemia Patients
Posted Date: Jul 13, 2021
- Investigator: Emily Curran
- Specialties: Cancer, Leukemia, Oncology
- Type of Study: Drug
This is a Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens. Experimental arm 1 will be DFP-10917 14-day continuous IV infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles. Control arm 2 will be Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment. Efficacy will be measured by complete remission rate and duration of complete remission.
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. Absence Of Uncontrolled Intercurrent Illnesses, Including Uncontrolled Infections, Cardiac Conditions, Or Other Organ Dysfunctions. Histologically Or Pathologically Confirmed Diagnosis Of Aml Based On Who Classification That Has Relapsed After, Or Is Refractory To, Two, Three, Or Four 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). No >Grade 1 Persistent Clinically Significant Toxicities From Prior Chemotherapy.Inadequate Cardiac (Left Ventricular Ejection Fraction =40%) Function. Wbc Count >15,000/Μl. No Current Malignancies Of Another Type. No Documented Or Known Clinically Significant Bleeding Disorder.
Phase 3, Leukemia
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Uc Cancer Center