Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06578247

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

About this study

This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
  • ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
  • Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
  • Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
  • Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment

Key Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
  • Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
  • Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
  • Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
  • Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
  • Leukapheresis;
  • Treatment for hyperleukocytosis with hydroxyurea;
  • Cranial radiotherapy for central nervous system (CNS) leukostasis;
  • Prophylactic intrathecal chemotherapy

Treatment and study plan

Quizartinib

Drug

Participants will receive quizartinib at 60 mg/day orally once daily

Other names: Test Product

Placebo

Drug

Participants will receive placebo at 60 mg/day orally once daily

Other names: Placebo Control

Chemotherapy

Drug

Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Other names: Cytarabine, Daunorubicin or Idarubicin, Standard Chemotherapy

Primary outcomes

  1. Overall Survival (Arm A vs Arm B)

    Time frame: Date of first patient randomized to the target number of deaths reached, up to approximately 42 months

    Overall survival (OS) is defined as the time from randomization until death from any cause.

Secondary outcomes

  1. Event-free survival (Arm A vs. Arm B)

    Time frame: Date of randomization up to approximately 42 months

    Event-free survival (EFS) is defined as time from randomization to date of failure to achieve CR at end of induction, relapse after CR, or death due to any cause, whichever occurs first

  2. Duration of complete response (Arm A vs. Arm B)

    Time frame: Date of randomization up to approximately 42 months

    Duration of complete response (DoCR) is defined as time from the first documented CR until documented relapse or death due to any cause, whichever comes first. As assessed by Independent Review Committee.

  3. Relapse-free survival (Arm A vs. Arm B)

    Time frame: Date of randomization up to approximately 42 months

    Relapse-free survival (RFS) is defined as time from randomization, for participants who achieve CR in the Induction Phase, until relapse or death due to any cause, whichever comes first. As assessed by Independent Review Committee .

  4. Complete remission rate (Arm A vs. Arm B)

    Time frame: At end of Induction Phase, up to approximately 120 days

    Complete remission rate (CR) is defined as proportion of of participants who achieved a CR. As assessed by Independent Review Committee.

  5. Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B)

    Time frame: At end of Induction Phase (Cycle 2 or Cycles 1 and 2), up to approximately 120 days

    Proportion of participants achieving CR with minimal or measurable residual disease (MRD) negativity. As assessed by Independent Review Committee.

  6. Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B)

    Time frame: Date of first dose up to 30 days after last dose, up to approximately 42 months

    Treatment-emergent adverse events (TEAE) are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of quizartinib/placebo to 30 days after the last dose date of quizartinib/placebo).

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

Acronym: QuANTUM-WILD

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Aug 29, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.