NCT04233346

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of this study is to determine the safety and efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the T315I mutation.

Conditions

• Chronic Myeloid Leukemia
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Ponatinib 30mg OD	Ponatinib 30mg OD
DRUG	Ponatinib 45mg OD	Ponatinib 45mg OD

Timeline

• Start date: 2020-07-09
• Primary completion: 2022-07-22
• Completion: 2025-12-31
• First posted: 2020-01-18
• Last updated: 2025-04-04

Locations

14 sites across 1 country: China