Status:
RECRUITING
A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is a clinical trial to evaluate the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies. TQB3455 is an isocitrate dehydrogenase 2(IDH2) inhibito...
Eligibility Criteria
Inclusion
- Patients meeting all of the following inclusion criteria can be included in this trial:
- Age ≥ 18 years old;
- According to the World Health Organization (WHO) classification, subjects diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) should meet one of the following criteria:
- Difficult to treat or recurrent (\>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group)
- Newly diagnosed AML subjects recognized by researchers as unable to receive standard treatment due to age, physical condition, or risk factors; (Joint group)
- MDS subjects belong to the following prognostic risk categories according to the revised International Prognostic Scoring System (IPSS-R):
- Extremely high-risk (\>6 points)
- High risk (\>4.5 points - ≤ 6 points)
- Medium risk (\>3 points - ≤ 4.5 points)
- Clearly indicating the presence of IDH2 gene mutation;
- Blood platelet (PLT) ≥20×10\^9/L； Or subjects with PLT\<20 × 10\^9/L, but recognized by the researchers as being caused by tumor reasons;
- Serum total bilirubin ≤ 1.5 × ULN (for Gilbert syndrome subjects, bilirubin ≤ 3 × ULN);
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min;
- Recovery of toxic reactions caused by surgery, radiation therapy, or other anti-tumor treatments to ≤ Grade I;
- Women should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Male participants must agree to use contraception during the study period and within 6 months after the end of the study period;
- The subjects voluntarily joined this study.
Exclusion
- Subjects who experience relapse after bone marrow transplantation;
- Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug;
- Individuals who have participated in clinical trials of other drugs within the four weeks prior to using the investigational drug;
- Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction;
- Subjects who have previously used targeted isocitrate dehydrogenase 2 (IDH2) inhibitors;
- The subject has uncontrolled systemic fungal, bacterial, or viral infections;
- High blood pressure subjects who are still poorly controlled despite drug treatment;
- Obvious cardiovascular diseases, such as heart failure classified as grade 2 or above by the New York Heart Association (NYHA), unstable angina in the past 3 months, myocardial ischemia or infarction, arrhythmia and grade I heart failure, or the presence of other factors at risk of prolonging the QT interval (such as arrhythmia, hypokalemia ≥ grade 3, family history of long QT interval);
- Severe leukemia complications that endanger life, such as uncontrolled bleeding, hypoxia or shock pneumonia, disseminated intravascular coagulation;
- Subjects known to have central nervous system leukemia or clinical symptoms of central nervous system leukemia;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- Subjects with active replication of hepatitis B virus and hepatitis C virus;
- Individuals with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- According to the researcher's judgment, there are accompanying diseases that pose a serious threat to the safety of the subjects or affect their ability to complete the study.
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06550713
Start Date
October 22 2019
End Date
December 1 2026
Last Update
August 13 2024
Active Locations (7)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Peking University international Hospital
Beijing, Beijing Municipality, China, 102206
3
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
4
Harbin The First Hospital
Harbin, Heilongjiang, China, 150010