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

NCT03926624 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2026-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

DFP-10917

DFP-10917 Powder for Injection. Active ingredient: 4-amino-1-(2-cyano-deoxy-β-D-arabinofuranosyl)-2(1H)-pyrimidinone monohydrochloride

DRUG

Cytarabine

cytosine arabinoside (ara-C)

DRUG

Azacitidine

Azacitidine

DRUG

Decitabine

Decitabine

DRUG

Mitoxantrone

Mitoxantrone

DRUG

Etoposide

Etoposide

DRUG

Fludarabine

Fludarabine

DRUG

Idarubicin

Idarubicin

DRUG

Venetoclax

Venetoclax

DRUG

Cladribine

Cladribine

Sponsors & Collaborators

  • Delta-Fly Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Tapan Kadia, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2026-01-07
Completion
2026-01-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03926624 on ClinicalTrials.gov