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Clinical Trials List

Protocol NumberCINC424A2353
NCT Number(ClinicalTrials.gov Identfier)NCT02598297

2016-03-31 - 2021-12-31

Phase III

Terminated3

ICD-9289.8

Other specified diseases of blood and blood-forming organs

A randomized, double blind, placebo-controlled, multi-center, Phase III study investigating the efficacy and safety of ruxolitinib in Early Myelofibrosis patients with high molecular risk mutations

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Lee-Yung Shin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 王銘崇 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 Terminated

Principal Investigator HSIN-AN HOU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Early Myelofibrosis

Objectives

Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aims to evaluate ruxolitinib in this patient population. Primary Objective To evaluate the effect of ruxolitinib in delaying progression of MF from early disease to more advanced disease stages

Test Drug

JAKAVI

Active Ingredient

INC424 (ruxolitinib)

Dosage Form

Tablet

Dosage

5mg

Endpoints

Efficacy assessments
 Spleen volume determination by MRI/CT
 Laboratory assessments confirming disease progression (Hb
decrease, WBC count and peripheral blood blast count)
 Bone marrow biopsy and aspirate for leukemic
transformation
 Symptom assessment using MF-7, EQ-5D

Safety assessments
Physical examination, laboratory assessments, ECG

Other assessments
 Changes in bone marrow fibrosis
 Assessment and characterization of the pharmacokinetics of
ruxolitinib
 Predictive biomarkers of response, pharmacodynamics
activity and disease burden
 Symptom changes using PGIC
 Spleen size dynamics using spleen length and volume

Inclution Criteria

Inclusion criteria
 Confirmed diagnosis of MF with bone marrow fibrosis of at
least Grade 1; irrespective of JAK2 mutational status
 Patients with at least one mutation in one of the five HMR
genes (ASXL1, EZH2, SRSF2 and IDH1/2)
 Patients with non-palpable spleen or spleen palpable ≤ 5 cm
from the left costal margin to the point of greatest splenic
protrusion
 Patients with MF-7 score of ≤ 15, with each individual
symptom score of ≤ 3

Exclusion Criteria

Exclusion criteria
 Patients with prior treatment with ruxolitinib or other JAK
inhibitors.

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    320 participants

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