問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberAC220-168
NCT Number(ClinicalTrials.gov Identfier)NCT06578247
Active

2024-12-30 - 2031-06-26

Phase III

Recruiting6

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

  • Trial Applicant

     Daiichi Sankyo Taiwan Ltd. 

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/16

Investigators and Locations

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉鴻霖 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator - - Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tung-Liang Lin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yao-Chung Liu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Leukemia

Objectives

The primary objective of this trial was to compare the effects of quizartinib versus placebo (in combination with standard induction and consolidation chemotherapy, followed by maintenance therapy for up to 36 cycles) on key indicators of overall survival in participants newly diagnosed with FLT3-ITD-negative acute myeloid leukemia.

Test Drug

Film-coated tablets

Active Ingredient

L01EX11000

Dosage Form

116

Dosage

20, 30

Endpoints

Compare the effects of quizartinib versus placebo (in combination with standard induction and consolidation chemotherapy, followed by maintenance therapy for up to 36 cycles) on the key endpoint of overall survival in participants newly diagnosed with FLT3-ITD-negative AML.

Inclution Criteria

Key Inclusion Criteria:

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.
≥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 a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment

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.
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.
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 prior to Day 1 of chemotherapy:

Leukapheresis;
Treatment for hyperleukocytosis with hydroxyurea;
Cranial radiotherapy for central nervous system (CNS) leukostasis;
Prophylactic intrathecal chemotherapy

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    700 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB