OncoMatch/Clinical Trials/NCT06382168
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Is NCT06382168 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including DFP-10917 and Venetoclax for leukemia, myeloid, acute.
Treatment: DFP-10917 · Venetoclax — This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: induction regimen
relapsed after, or is refractory to, up to 2 prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine with/without venetoclax), or targeted therapy (e.g., FLT-3, IDH 1/2, BCL-2, monoclonal antibody)
Cannot have received: venetoclax (venetoclax)
Exception: Venetoclax exposure in more than 1 prior regimen
Venetoclax exposure in more than 1 prior regimen
Cannot have received: hematopoietic stem cell transplantation
Prior hematopoietic stem cell transplantation
Cannot have received: anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents
Exception: within 14 days of the first day of study treatment or within 5 half-lives prior to first dose of study treatment
Prior exposure to anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents within 14 days of the first day of study treatment or within 5 half-lives prior to first dose of study treatment
Cannot have received: biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent
Exception: within 14 days prior to first dose of study drug
Prior exposure to biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent within 14 days prior to first dose of study drug
Lab requirements
Kidney function
Creatinine clearance >30 mL/min (by Cockcroft-Gault method)
Liver function
Total serum bilirubin <1.5 × upper limit of normal unless due to Gilbert's syndrome, leukemic organ involvement, hemolysis or considered an effect of regular blood transfusions; ALT and AST <3 × upper limit of normal, unless due to leukemic organ involvement
Adequate organ function as defined by the following laboratory values: Creatinine clearance >30 mL/min (by Cockcroft-Gault method), Total serum bilirubin <1.5 × upper limit of normal unless due to Gilbert's syndrome, leukemic organ involvement, hemolysis or considered an effect of regular blood transfusions, Alanine aminotransferase and aspartate aminotransferase <3 × upper limit of normal, unless due to leukemic organ involvement.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Chao Family Comprehensive Cancer Center · Orange, California
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center · Winston-Salem, North Carolina
- University of Vermont Cancer Center · Burlington, Vermont
- University of Virginia Cancer Center · Charlottesville, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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