Trial Title:
A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
NCT ID:
NCT06550713
Condition:
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
Conditions: Official terms:
Leukemia, Myeloid, Acute
Preleukemia
Hematologic Neoplasms
Myelodysplastic Syndromes
Azacitidine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3455 tablet+Azacitidine for Injection
Description:
TQB3455 is a selective IDH2 mutant enzyme inhibitor. Azacitidine for injection is a
cytosine nucleoside drug that is used for demethylation therapy.
Arm group label:
TQB3455 tablet and Azacitidine for Injection
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) 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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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:
1. Difficult to treat or recurrent (>5% of primitive cells reappear in the bone
marrow after complete remission) AML; (Single drug group)
2. 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):
1. Extremely high-risk (>6 points)
2. High risk (>4.5 points - ≤ 6 points)
3. 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 Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Jiang, Master
Phone:
13601164350
Email:
2516735116@qq.com
Facility:
Name:
Peking University international Hospital
Address:
City:
Beijing
Zip:
102206
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Min Ouyang, Doctor
Phone:
13522691907
Email:
ouyangmin@pkuih.edu.cn
Facility:
Name:
The Second Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xuejun Zhang, Doctor
Phone:
13722781112
Email:
zhxjhbmu@126.com
Contact backup:
Last name:
Zhiqing Zhang, Doctor
Phone:
15803210627
Email:
777yyy@sina.com
Facility:
Name:
Harbin The First Hospital
Address:
City:
Harbin
Zip:
150010
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tiejun Gong, Master
Phone:
13836027737
Email:
arc@sina.con
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Zip:
201306
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chunkang Chang, Doctor
Phone:
18930177640
Email:
changchunkang@sina.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongbing Ma, Doctor
Phone:
18980605801
Email:
hongbingma@foxmail.com
Facility:
Name:
People's Hospital of Tianjin
Address:
City:
Tianjin
Zip:
300121
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xingli Zhao, Postdoc
Phone:
13752255454
Email:
tjsrmyyxyk@163.com
Start date:
October 22, 2019
Completion date:
December 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06550713
