Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia - Chronic Phase
Conditions
Brief summary
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
Sponsors
Shenzhen TargetRx Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years) | EFS measures time duration between randomization to disease progression, treatment failure, loss of efficacy, development of new mutation, or death, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematologic Response | From randomization to end of study (estimated study duration: 5 years) | Rate of occurence of complete hematologic response (CHR). |
| Cytogenetic Response | from randomization to end of study (estimated study duration: 5 years) | Rate of occurence of Major Cytogenetic Response (MCyR) and Complete Cytogenetic Response (CCyR). |
| Molecular Response | from randomization to end of study (estimated study duration: 5 years) | Rate of Occurence for Major Molecular Response (MMR) |
| Progression Free Survival (PFS) | from randomization to end of study (estimated study duration: 5 years) | Duration between enrollment to progressive disease or death of any cause |
| Overall Survival (OS) | from randomization to end of study (estimated study duration: 5 years) | Duration between enrollment to death of any cause |
| Treatment Emergent Adverse Event (TEAE) | from randomization to end of study (estimated study duration: 5 years) | To record and analyse the occurence and frequency of adverse events during the study |
Outcome results
None listed