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 Patients in Second, Third, or Fourth Salvage

About this Study

The purpose of this study is to compare the rate of complete response (CR) and duration of CR, in patients with relapsed or refractory AML to two, three, and four prior inductions regimens that my have included intensive chemotherapy, who will receive DFP-10917 versus non-intensive reinduction or intensive re-induction as a second, third, and fourth salvage treatment.

Sponsor Protocol ID:D18-11141
IRB Number:2021-0596
Actively Enrolling
Phase 3
June 30, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Histologically or pathologically confirmed diagnosis of AML that has relapsed after , or is refractory (not responding to current treatment) to two, three, or four prior induction regimens that may have included intensive chemotherapy
  • 18 years of age or older
  • Absence of active central nervous system (CNS) involvement by leukemia
  • No uncontrolled intercurrent illnesses, including infections, cardiac conditions, or other organ problems

Exclusion Criteria
  • Interval from prior treatment to time of study administration is less than 2 week for cytotoxic or less than 5 half-lives for noncytotoxic agents
  • Inadequate cardiac function
  • For patients with prior hematopoietic stem cell transplant (HSCT):  Less than 3 months since HSCT, less than grade 1 acute Graft versus Host Disease (GvHD ), and less than grade 1 chronic GvHD
  • Pregnant or lactating women
  • Current cancers of another type, except previously treated or currently controlled prostate cancer, adequately treated in situ cervical cancer or basal cell skin cancer, or other cancer with no evidence of disease for 2 years or more
  • Acute promyelocytic leukemia (APL)
  • Known HIV, active HBV or active HCV infection
  • Documented or known clinically significant bleeding disorder

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Elkins, Stephanie L, M.D.
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