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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
TGRX-678
DrugAll patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Experimental: TGRX-678Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Hematologic Response (MaHR)
Number of patients who reached, and rate of occurence of major hematologic response, including those who reached complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR and NEL are defined per China national treatment guideline for CML (ver. 2022). Indicators for hematologic responses will be obtained via peripheral blood tests.
Time frame
At screening, on Day 1 of every treatment cycle (each cycle is 28 days) and at end of treatment; average of study duration is 3.5 yearsSecondary outcomes
1
Cytogenetic Response
Number of patients who reached, and rate of occurence of cytogenetic response, including those with major cytogenetic response (MCyR) or complete cytogenetic response (CCyR). Cytogenetic responses are defined per China national treatment guideline for CML (ver. 2022). Indicators for cytogenetic responses will be obtained via bone marrow biopsy.
Time frame
At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years2
Major Molecular Response (MMR)
Number of patients who reached, and rate of occurence of MMR. Cytogenetic response is defined per China national treatment guideline for CML (ver. 2022). Indicators for molecular responses will be obtained via genetic testing on transcript levels of BCR-ABL gene.
Time frame
At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years3
Time to Response (TTR)
TTR defined by the time from the start of treatment to the first efficacy response; TTR as evaluated by investigator
Time frame
At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years4
Duration of Response (DOR)
DOR defined as the duration from first occurence of treatment response to progressive disease/relapse; DOR as evaluated by investigator
Time frame
At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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