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ACTIVE NOT RECRUITING
NCT04233346
PHASE2

The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation

Sponsor: Otsuka Beijing Research Institute

View on ClinicalTrials.gov

Summary

This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia

Official title: A Phase II Multi-center, Randomized, Open-label Study of Ponatinib in Chinese Patients With Chronic Myeloid Leukemia Who Have Failed Prior TKIs or With T315I Mutation, or Ph+ALL Who Have Failed Prior TKIs or With T315I Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

93

Start Date

2020-07-09

Completion Date

2025-12-31

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DRUG

Ponatinib 30mg OD

Ponatinib 30mg OD

DRUG

Ponatinib 45mg OD

Ponatinib 45mg OD

Locations (14)

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shenzhen Second People's Hospital

Shenzhen, Shenzhen, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, China

1st affiliated hospital, Peking University

Beijing, China

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, China