RECRUITING

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

Talk to us

Conditions

Leukemiaacute myeloid leukemiaquizartinibFLT3FLT3-ITDChemotherapyFLT3-WT

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-11-19
Study Completion:2030-06-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06578247

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  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 receiving standard "7+3" induction chemotherapy regimen as specified in the protocol
  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 for other neoplasms or autoimmune/rheumatologic conditions.
  3. * Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, 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:
  6. 1. Leukapheresis;
  7. 2. Treatment for hyperleukocytosis with hydroxyurea;
  8. 3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
  9. 4. Prophylactic intrathecal chemotherapy;
  10. 5. Growth factor/cytokine support.

Contacts and Locations

Study Contact

Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
908-992-6400
CTRinfo_us@daiichisankyo.com

Principal Investigator

Global Clinical Leader
STUDY_DIRECTOR
Daiichi Sankyo

Study Locations (Sites)

City of Hope Phoenix
Goodyear, Arizona, 85338
United States
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
United States
University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
Ucsf - School of Medicine
San Francisco, California, 94115
United States
Stanford University School of Medicine- Parent
Stanford, California, 94305
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Yale University
New Haven, Connecticut, 06510
United States
Mayo Clinic Hospital
Jacksonville, Florida, 32224
United States
Florida Hospital Cancer Institute - Kissimmee
Kissimmee, Florida, 34741
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Moffit Cancer Center
Tampa, Florida, 33612
United States
Augusta University
Augusta, Georgia, 30912
United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University of Kentucky
Lexington, Kentucky, 40504
United States
Ochsner Medical Center - New Orleans
New Orleans, Louisiana, 70121
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Minnesota Medical School - Twin Cities Campus
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University
Saint Louis, Missouri, 63110
United States
Thomas Jefferson Univ Hosp
Haddonfield, New Jersey, 08033
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Cancer Center - Main
New York, New York, 10065
United States
Upstate University Hospital
Syracuse, New York, 13210
United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States
Oregon Health & Science University (Ohsu)
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Tristar Bone Marrow Transplant
Nashville, Tennessee, 37203
United States
South Austin Medical Center
Austin, Texas, 78745
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030
United States
Uva Health System
Charlottesville, Virginia, 22908
United States
Virginia Commonwealth University (Vcu) Massey Cancer Center
Richmond, Virginia, 23229
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

  • Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-19
Study Completion Date2030-06-26

Study Record Updates

Study Start Date2024-11-19
Study Completion Date2030-06-26

Terms related to this study

Keywords Provided by Researchers

  • acute myeloid leukemia
  • quizartinib
  • FLT3
  • FLT3-ITD
  • Chemotherapy
  • FLT3-WT

Additional Relevant MeSH Terms

  • Leukemia