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Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old

NCT04687761 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2026-05-13

No results posted yet for this study

Summary

A phase I-II trial based on the combination of three drugs regimen LDAC or Azacitidine + Venetoclax + Quizartinib that in this population could be well tolerated by a sequential type administration. The first objective is to achieve rapid control of the disease, using two different schemes, one based in Azacitidine and the other in LDAC, by dose escalation in phase I of the trial. The second goal is to prevent relapse through a maintenance schedule. Phase II will study the efficacy and safety of the recommended dose for Phase II

Conditions

  • Leukemia, Myeloid, Acute
  • De Novo
  • Age More 60yr

Interventions

DRUG

Azacitidine

AZA 75 mg/m2/daily SC days 1 to 7 or on a 5-on/2-off \[weekend\]/2-on schedule in 28-day cycle

DRUG

Venetoclax

Venetoclax (ramp-up) 400 mg/daily oral days 1 to 28

DRUG

Quizartinib

Quizartinib 40 mg/daily oral, days, 8 to 28

DRUG

Cytarabine

Low-dose subcutaneous cytarabine (LDAC) 20 mg/m2/daily SC, days 1 to 10

DRUG

Venetoclax

Venetoclax (ramp-up) 600 mg/daily oral, days 1 to 28

DRUG

Quizartinib

Quizartinib 40 mg/daily oral, days 8 to 28

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Pau Montesinos, MD · Hospital Universitario La Fe

  • Juan Bergua, MD · Hospital San Pedro Alcántara

  • Carmen López-Carrero García · Fundación PETHEMA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2024-11-30
Completion
2025-05-30

Countries

  • Spain

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 NCT04687761 on ClinicalTrials.gov