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Trial Title:
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
NCT ID:
NCT06453902
Condition:
Chronic Myeloid Leukemia
Accelerated Phase CML
Conditions: Official terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Accelerated Phase
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TGRX-678
Description:
All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally
Arm group label:
Experimental: TGRX-678
Summary:
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
Detailed description:
This Phase II study is of single-arm, open-label and multi-center designs to study safety
and efficacy profiles of TGRX-678 in CML-AP patients. Patients need to have medical
history of failing treatment(s) from third-generation TKI drugs. Patients with or without
T315I mutation is enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- For patients with T315I mutation, the patients much received Olverembatinib or
Ponatinib treatment
- Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or
cytogenetic tests
- ECOG score
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Start date:
June 15, 2024
Completion date:
December 15, 2027
Lead sponsor:
Agency:
Shenzhen TargetRx, Inc.
Agency class:
Industry
Collaborator:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Shenzhen TargetRx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06453902
