Tests TQB3455 tablets in adults with acute myeloid leukemia or myelodysplastic syndrome
Tests the TQB3455 tablet, alone or with azacitidine, in adults with leukemia or MDS.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
Key facts
- Where
- Beijing, Chengdu, Harbin, Shanghai, Shijiazhuang, and Tianjin, ChinaSee the 7 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who have an IDH2 gene mutation. It tests the tablet TQB3455, alone or with azacitidine.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- AML that is hard to treat or has come back (>5% of primitive cells reappear in the bone marrow after complete remission), or newly diagnosed AML where the researchers think standard treatment is not possible because of age, physical condition or risk factors. MDS in the extremely high, high or medium risk groups (IPSS-R).
- Earlier treatment
- Cannot have had an IDH2 inhibitor before. Cannot have had anti-cancer drug treatment or radiation within 3 weeks before the study drug. Side effects from earlier treatment must have eased to Grade I or less.
- Biomarker or test result
- An IDH2 gene mutation must be clearly shown.
Main reasons for not taking part
- Relapse after a bone marrow transplant
- Leukemia in the central nervous system
- Uncontrolled infection, or active hepatitis B or C virus
- HIV positive, other immune system deficiency, or a past organ transplant
- Serious heart disease, or trouble taking tablets by mouth
Read by machine on 12 November 2026.
Where in China
- Peking University International HospitalBeijing, ChinaContact: Min Ouyang, DoctorNot yet recruiting
- Peking University People's HospitalBeijing, ChinaContact: Hao Jiang, MasterTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaContact: Hongbing Ma, DoctorNot yet recruiting
- Harbin The First HospitalHarbin, ChinaContact: Tiejun Gong, MasterNot yet recruiting
- Shanghai Sixth People's HospitalShanghai, ChinaContact: Chunkang Chang, DoctorNot yet recruiting
- The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Xuejun Zhang, DoctorNot yet recruiting
- People's Hospital of TianjinTianjin, ChinaContact: Xingli Zhao, PostdocNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Trial code
- NCT06550713
- Record updated
- 13 August 2024
- Original description
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).Read full original descriptionShow less
Phase I Clinical Trial Protocol for Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies
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).
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; High blood pressure subjects who are still poorly controlled despite drug treatment; The subject has uncontrolled systemic fungal, bacterial, or viral infections; Severe leukemia complications that endanger life, such as uncontrolled bleeding, hypoxia or shock pneumonia, disseminated intravascular coagulation; 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; 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); Subjects known to have central nervous system leukemia or clinical symptoms of central nervous system leukemia.