TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen TargetRx Co., Ltd.
About this trial
A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment
Eligibility criteria
Qualifiers
Willing to consent
18 years of age or above at time of screening; both sexes eligible
Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment
For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
Disqualifiers
Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose
Reception of other anti-tumor treatments
In need for immune suppressive treatment
Usage of drugs associated with Torsades de Pointes within 1 months before screening
Trial design
Treatments tested in this trial
- TGRX-678
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Shenzhen TargetRx Co., Ltd.
Lead sponsor
Peking University People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Chinese Academy of Medical Sciences
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Shenzhen Second People's Hospital
Collaborator
Ruijin Hospital
Collaborator
Shengjing Hospital
Collaborator
Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov