Actively Recruiting
A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-08-13
100
Participants Needed
7
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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) inhibitor . This project is divided into two stages. The first stage aims to evaluate the safety and tolerability of single or multiple oral administration of TQB3455 tablets in subjects with malignant hematological tumors. The second phase aims to evaluate the efficacy and safety of TQB3455 tablets alone or in combination with azacitidine in subjects with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
CONDITIONS
Official Title
A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) according to WHO classification
- For AML: difficult to treat or recurrent AML with >5% primitive cells after remission, or newly diagnosed AML unable to receive standard treatment due to age, physical condition, or risk factors
- For MDS: prognostic risk category of medium risk, high risk, or extremely high risk according to revised IPSS-R
- Confirmed presence of IDH2 gene mutation
- Blood platelet count ≥ 20 × 10^9/L, or platelet count < 20 × 10^9/L due to tumor reasons
- Serum total bilirubin ≤ 1.5 × upper limit normal (ULN), or ≤ 3 × ULN for Gilbert syndrome
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50 ml/min
- Recovery from toxic reactions of surgery, radiation, or other anti-tumor treatments to Grade I or less
- Women agree to use contraception during the study and for 6 months after
- Men agree to use contraception during the study and for 6 months after
- Voluntary participation in the study
You will not qualify if you...
- Relapse after bone marrow transplantation
- Received systemic anti-tumor or radiation therapy within 3 weeks before the investigational drug
- Participated in other drug clinical trials within 4 weeks prior to investigational drug use
- Conditions affecting oral medication such as swallowing difficulty, gastrointestinal resection, chronic diarrhea, or intestinal obstruction
- Prior use of targeted IDH2 inhibitors
- Uncontrolled systemic fungal, bacterial, or viral infections
- Poorly controlled high blood pressure despite medication
- Significant cardiovascular diseases including NYHA grade 2 or above heart failure, recent unstable angina, myocardial ischemia or infarction, arrhythmias, or risk factors for prolonged QT interval
- Severe leukemia complications like uncontrolled bleeding, hypoxia, shock pneumonia, or disseminated intravascular coagulation
- Known central nervous system leukemia or symptoms thereof
- History of psychotropic drug abuse or untreated mental disorders
- Active hepatitis B or C virus replication
- History of immunodeficiency including HIV or organ transplantation
- Other serious diseases affecting safety or study completion as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Peking University international Hospital
Beijing, Beijing Municipality, China, 102206
Not Yet Recruiting
3
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
4
Harbin The First Hospital
Harbin, Heilongjiang, China, 150010
Not Yet Recruiting
5
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 201306
Not Yet Recruiting
6
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
7
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, China, 300121
Not Yet Recruiting
Research Team
H
Hao Jiang, Master
CONTACT
W
Wenbing Duan, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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