Clinical Trial 23442

• Overview

  Study Title:

  A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy and Administered as Maintenace Therapy in Adult Patients with Newly Diagnosed FLT3-ITD (-) Acute Myeloid Leukemia

  Summary:

  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.

  Objective:

  Primary Objective: 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 participants with newly diagnosed FLT3-ITD negative AML. Secondary Objectives: To compare the following in participants treated with quizartinib vs placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles): Event-free survival (EFS). Duration of complete response (DoCR). Relapse-free survival (RFS). Complete remission (CR) rate. CR with minimal or measurable residual disease (MRD) negativity. Further characterize the safety profile of quizartinib administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles. Assess the pharmacokinetics (PK) of quizartinib and its metabolite (AC886).

• Treatments

  Therapies:

  Chemotherapy (NOS); Tyrosine Kinase Inhibitor

  Medications:

  Cytarabine (Cytosine Arabinoside); Placebo (); Quizartinib ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or tests.
  • 18 years or older 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 receiving standard "7+3" induction chemotherapy regimen as specified in the protocol.
  • "Other criteria apply

• Exclusion Criteria

  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 for other neoplasms or autoimmune/rheumatologic conditions.
  • Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, 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: 1. Leukapheresis 2. Treatment for hyperleukocytosis with hydroxyurea 3, Cranial radiotherapy for central nervous system (CNS) leukostasis 4. Prophylactic intrathecal chemotherapy 5. Growth factor/cytokine support.
  • Other criteria apply

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