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A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment

NCT04112589 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-03-14

No results posted yet for this study

Summary

This is a multicenter, prospective, non-randomized, Phase I-II trial to assess the efficacy and safety of the combination of oral quizartinib and FLAG-IDA chemotherapy schedule (FLAG-QUIDA regimen) in first relapsed/refractory AML (acute myeloid leukemia) patients.

Conditions

Interventions

DRUG

Quizartinib

Quizartinib at different doses in the phase I (40mg-14 days; 60mg-14 days; 60mg-7days, 40mg-7days). RP2D in the phase II part.

DRUG

Fludarabine

30 mg/m2 intravenous days 1 to 4 of the cycle

DRUG

Cytarabine

2 g/m 2 intravenous days 1 to 4 (1 g/m2 in patients older than 59) of the cycle

DRUG

Idarubicin

10 mg/ 2 intravenous days 1 to 3 of the cycle

DRUG

glycosylated G-CSF

daily dose of 300 mcg/m 2 , from day -1 until day 5 of the cycle

Sponsors & Collaborators

  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

    collaborator INDUSTRY

  • Syntax for Science, S.L

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Pau Montesinos, MD · Trial Coordinator, Institution Contact

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-26
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04112589 on ClinicalTrials.gov