Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Daiichi Sankyo

NCT ID: NCT06578247

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Quizartinib (drug), Placebo (drug), Chemotherapy (drug)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
Quizartinib — drug: Participants will receive quizartinib at 60 mg/day orally once daily · Placebo — drug: Participants will receive placebo at 60 mg/day orally once daily · Chemotherapy — drug: Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
700
Started
2024-11-19
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for leukemia
  • • Phase3 - 700 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with leukemia

Where?

  • • Birmingham - Queen Elizabeth Hospital
  • • Harrow - Northwick Park Hospital
  • • London - King'S College Hospital
  • • London - Hammersmith Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Leukemia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

Biomarkers mentioned

ABL positiveFLT3

What the study is looking for

  • ✓Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board...
  • ✓≥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...
  • ✓activity scale (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
  • ✓Participant is a candidate for standard "7+3" induction drug treatment regimen as specified in the protocol per...

Who cannot take part

  • ✗Diagnosis of AML secondary to prior drug treatment or radiotherapy.
  • ✗Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR)...
  • ✗Prior treatment for AML, except for the following allowances prior to Day 1 of drug treatment:
  • ✗Leukapheresis;
  • ✗Treatment for hyperleukocytosis with hydroxyurea;
See the full criteria
Key Inclusion Criteria: 1. 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. 2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening). 3. Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening) 4. Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2. 5. Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment Key Exclusion Criteria: 1. 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). 2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy. 3. 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. 4. 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. 5. Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy: 1. Leukapheresis; 2. Treatment for hyperleukocytosis with hydroxyurea; 3. Cranial radiotherapy for central nervous system (CNS) leukostasis; 4. Prophylactic intrathecal chemotherapy

Where Is This Study? (8 UK sites)

Queen Elizabeth Hospital

Birmingham, United Kingdom

Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

Northwick Park Hospital

Harrow HA1 3UJ, United Kingdom

King'S College Hospital

London SE5 9NU, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Hammersmith Hospital

London W12 0HS, United Kingdom

Maidstone Hospital

Maidstone ME16 9QQ, United Kingdom

Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

Manchester Royal Infirmary

Manchester M13 9WL, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Churchill Hospital

Oxford OX3 7LJ, United Kingdom

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635
Data sourced from ClinicalTrials.gov · Last verified: 2026-06