RECRUITING

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

Description

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).

Conditions

Leukemia
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Leukemia

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Leukemia
Intervention / Treatment

-

Contacts and Locations

Goodyear

City of Hope Phoenix, Goodyear, Arizona, United States, 85338

Phoenix

Mayo Clinic - Phoenix, Phoenix, Arizona, United States, 85054

Tucson

University of Arizona Cancer Center, Tucson, Arizona, United States, 85724

San Francisco

Ucsf - School of Medicine, San Francisco, California, United States, 94115

Stanford

Stanford University School of Medicine- Parent, Stanford, California, United States, 94305

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Jacksonville

Mayo Clinic Hospital, Jacksonville, Florida, United States, 32224

Kissimmee

Florida Hospital Cancer Institute - Kissimmee, Kissimmee, Florida, United States, 34741

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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 receiving standard "7+3" induction chemotherapy regimen as specified in the protocol
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Daiichi Sankyo,

Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

2030-06-26