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Not yet recruiting NCT07489755

TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients

Phase III Interventional Chronic Myelogenous Leukemia Chronic Myelogenous Leukemia - Chronic Phase

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TGRX-678, TKI.
Who it may be relevant to
Registry conditions: Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia - Chronic Phase. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Open-label, Multi-center Phase III Study Evaluating Efficacy and Safety of TGRX-678 Comparing to Investigator Selected Tyrosine Kinase Inhibitor (TKI) in CML-CP Patients Resistant From or Intolerant to at Least 3 TKI Treatments

Overview

A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs

Detailed description

This Phase III study is of randomized, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-CP patients. Patients need to have medical history of failing treatment(s) from at least 3 TKI drugs. Patients with or without T315I mutation is enrolled. Patients are randomized to either TGRX-678 treatment or TKI treatment at investigator's decision.

Interventions

  • Drug TGRX-678
    Patients will be given TGRX-678 for oral administration
  • Drug TKI
    Patient will take TKI of investigator's choice for oral administration

Primary outcome measures

  • Event-free survival (EFS) [Time frame: from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years)]
Secondary outcome measures (6)
  • Hematologic Response [Time frame: From randomization to end of study (estimated study duration: 5 years)]
  • Cytogenetic Response [Time frame: from randomization to end of study (estimated study duration: 5 years)]
  • Molecular Response [Time frame: from randomization to end of study (estimated study duration: 5 years)]
  • Progression Free Survival (PFS) [Time frame: from randomization to end of study (estimated study duration: 5 years)]
  • Overall Survival (OS) [Time frame: from randomization to end of study (estimated study duration: 5 years)]
  • Treatment Emergent Adverse Event (TEAE) [Time frame: from randomization to end of study (estimated study duration: 5 years)]

Eligibility criteria

Inclusion criteria

  • Willing to consent and to follow study procedures
  • 18 years of age or above at time of screening; both sexes eligible
  • Diagnosed with CML-CP and was intolerant to or failed from at least 3 TKI treatments
  • ECOG score >= 2
  • Adequate hematological indicators and have not used blood products or Colony-Stimulating Factor (CSF)
  • Adequate kidney, liver and coagulation function
  • Adequate QTc interval as confirmed by electrocardiogram (ECG) test
  • Negative pregnancy result at screening for female patients of child-bearing potential
  • Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)

Exclusion criteria

  • Reception of TKI treatment or other anti-tumor treatments prior to first dose
  • History or presence of extramedullary leukemia
  • History of progression to CML-AP or BP
  • Presence or having uncontrolled condition for cardiovascular diseases
  • History of severe hemorrhagic disease
  • Presence of malabsorption or other conditions that may affect drug absorption
  • History of other primary malignancy within 5 years
  • Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)
  • In need for or having long-term immune suppressive treatment
  • Reception of major surgery 28 days before first dose
  • Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade >=1
  • Presence of other conditions that the investigators or medical monitor deem unfit for the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07489755 · TGRX-678-3001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗