Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Delta-Fly Pharma, Inc.
Study ID
NCT03926624
Phase
PHASE3
Status
Terminated

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DFP-10917 — DRUG
    DFP-10917 Powder for Injection. Active ingredient: 4-amino-1-(2-cyano-deoxy-β-D-arabinofuranosyl)-2(1H)-pyrimidinone monohydrochloride
  • Cytarabine — DRUG
    cytosine arabinoside (ara-C)
  • Azacitidine — DRUG
    Azacitidine
  • Decitabine — DRUG
    Decitabine
  • Mitoxantrone — DRUG
    Mitoxantrone
  • Etoposide — DRUG
    Etoposide
  • Fludarabine — DRUG
    Fludarabine
  • Idarubicin — DRUG
    Idarubicin
  • Venetoclax — DRUG
    Venetoclax
  • Cladribine — DRUG
    Cladribine

Study Details

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: 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. Control arm: 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.

Key Dates

Start date
Nov 22, 2019
Status verified
Feb 2025
Primary completion
Jan 7, 2026
Completion
Jan 7, 2026

Study Design

Enrollment
167 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    DFP-10917 Dose: 6 mg/m²/day administered by continuous infusion for 14 days followed by a 14-day resting period per 28-day treatment cycle. If a patient experiences a significant treatment-related 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: Control
    Non-Intensive: * LoDAC: 20 mg SC BID 10 days * Azacitidine: 75 mg/m²/day SC 7 days(or 5+2) * Decitabine: CIV 20 mg/m²x5 days * Venetoclax + LoDAC/Azacitidine/Decitabine:LoDAC-Venetoclax ramp-up to 600 mgxday. Cytarabine SC 20 mg/m²xday D1-10. Azacitidine or Decitabine-Venetoclax ramp-up to 400 mgxday. Azacitidine IV or SC 75 mg/m² D1-7. Decitabine IV 20 mg/m² on D1-5 or 1-10. Intensive: * High DAC: cytarabine 1-2 g/m² up to 5 days, max total dose 10 g/m² * FLAG: D1-5: fludarabine 30 mg/m² IV for 30min, D1-5: cytarabine 1-2 g/m² for 4hr daily x 5 \& G-CSF 5 mcg/kg or 300 mcg/m² until PMN recovery, with or without idarubicin D1-3 8 mg/m² IV dailyx3 (FLAG-Ida) * MEC: D1-6: mitoxantrone 6 mg/m² IV bolus, etoposide 80 mg/m² IV 1hr \& cytarabine 1g/m² IV 6hr. * CLAG/M or Ida = cladribine 5 mg/m² D1-5, cytarabine 2 g/m² D1-5, G-CSF 300 μg D0-5, mitoxantrone 10 mg/m² D1-3 or Idarubicin 10 mg/m² D1-3. * Intermediate DAC: cytarabine 20 mg/m² IV dailyx5

Primary Outcome Measure

Complete remission (CR) rate [ Time Frame: 3 years ]

Locations (39)

FacilityCityStateZIPSite coordinators
O'Neal Comprehensive Cancer CenterBirminghamAlabama35294-
Banner MD AndersonGilbertArizona85234-
HonorHealth (VGPCC Cancer Transplant Institute)ScottsdaleArizona85258-
The University of Arizona Cancer CenterTucsonArizona85724-5024-
University of CaliforniaIrvineCalifornia92697-
UCLALos AngelesCalifornia90095-
UF-Health Cancer Center GainesvilleGainesvilleFlorida32608-
Baptist MD AndersonJacksonvilleFlorida32207-
UF-Health JacksonvilleJacksonvilleFlorida32209-
AdventHealth Medical Group Blood and Marrow Transplant at OrlandoOrlandoFlorida32804-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
Rush UniversityChicagoIllinois60612-
Decatur Memorial Hospital-Cancer Care Specialists of Central ILDecaturIllinois62526-
Loyola University Medical CenterHinesIllinois60153-
Franciscan Health IndianapolisIndianapolisIndiana46237-
The University of Kansas Cancer CenterWestwoodKansas66205-
University of KY- Markey Cancer CenterLexingtonKentucky40536-
Norton Cancer InstituteLouisvilleKentucky40241-
Ochsner Benson Cancer CenterJeffersonLouisiana70121-
Tulane UniversityNew OrleansLouisiana70118-
Henry Ford Cancer InstituteDetroitMichigan48202-
The University of Mississippi Medical CenterJacksonMississippi39216-
New York Medical CollegeValhallaNew York10595-
Novant Health Cancer Institute - Elizabeth (Hematology)CharlotteNorth Carolina28204-
East Carolina UniversityGreenvilleNorth Carolina27834-
Vidant OncologyKinstonNorth Carolina28501-
Novant Health Cancer Institute - Forsyth (Hematology)Winston-SalemNorth Carolina27103-
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Gabrail Cancer CenterCantonOhio44718-
University of Cincinnati Cancer CenterCincinnatiOhio45267-
Seidman Cancer Center, University Hospitals, Cleveland Medical CenterClevelandOhio44106-
Prisma Health Cancer InstituteGreenvilleSouth Carolina29605-
Avera Medical GroupSioux FallsSouth Dakota57105-
UT SouthwesternDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-
MD Anderson Cancer CenterHoustonTexas77030-
University of Vermont Medical CenterBurlingtonVermont05401-
University of Virginia Health SystemCharlottesvilleVirginia22903-
Multicare Institute for Research and InnovationSpokaneWashington99218-

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O'Neal Comprehensive Cancer Center· Birmingham, ALBanner MD Anderson· Gilbert, AZHonorHealth (VGPCC Cancer Transplant Institute)· Scottsdale, AZThe University of Arizona Cancer Center· Tucson, AZUniversity of California· Irvine, CAUCLA· Los Angeles, CA

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