MedTrace Logo

Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physician's Choice in Newly Diagnosed FLT3-ITD+ AML

NCT04676243 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-05-25

No results posted yet for this study

Summary

The orally administered second-generation bis-aryl urea tyrosine kinase inhibitor quizartinib is very specific for FLT3, has a high capacity for sustained FLT3-inhibition and an acceptable toxicity profile. Furthermore, single agent quizartinib doubled the response rate as compared to standard of care in a randomized study in r/r-AML. Combination therapy of quizartinib with intensive standard induction chemotherapy has been shown to be safe and moreover, single agent quizartinib maintenance therapy is feasible even after allogeneic HCT.

The efficacy of quizartinib in combination with intensive induction and post-remission therapy including allogeneic HCT and single agent quizartinib as maintenance therapy is evaluated by this protocol. This approach is compared in a randomized manner to the current standard of care.

Conditions

Interventions

DRUG

Quizartinib

20 mg coated tablets, orally administered

DRUG

Treatment according to Physician's Choice

Usually daunorubicin/ cytarabine or idarubicin/Cytarabine plus FLT3 inhibitor (usually midostaurin)

DRUG

Standard of Care Chemotherapy

Daunorubicin/ Cytarabine or Idarubicin/Cytarabine

Sponsors & Collaborators

  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

    collaborator INDUSTRY

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Richard F Schlenk, Prof Dr · NCT Trial Center, University Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2025-05-31
Completion
2025-12-31

More Related Trials

Entities

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 NCT04676243 on ClinicalTrials.gov