UPCC 49424 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 (QuANTUM-Wild) (QuANTUM-WILD)

Study on Investigational Medication with Chemotherapy for Blood and Bone Marrow Cancer

Enrolling By Invitation
18 years - 70 years
All
Phase 3
700 participants needed
1 Location

Brief description of study

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).

Detailed description of 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Leukemia
  • Age: 18 years - 70 years
  • Gender: All

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

This study investigates the effects of an investigational medication in combination with chemotherapy for adults with newly diagnosed FLT3-ITD negative acute myeloid leukemia (AML). This trial will compare the investigational medication to a placebo to see if it improves overall survival in these patients.

Participants will receive either the investigational medication or a placebo, along with standard chemotherapy. The study involves testing for FLT3-ITD mutation status in a central laboratory. The study procedures include induction and consolidation chemotherapy, followed by maintenance therapy for up to 36 cycles.

  • Who can participate: Adults aged 18 to 70 years, newly diagnosed with primary AML, and who are candidates for standard induction chemotherapy can participate. Key exclusion criteria include having certain types of leukemia or prior treatments for AML.
  • Study details: Participants will take part in a randomized trial where they will receive either the investigational medication or a placebo, along with standard chemotherapy. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 02 Jul 2026. Study ID: 24-2082
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