Trial Title:
A Study of TQB3454 Tablets in Patients With Blood Tumors
NCT ID:
NCT06218771
Condition:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Conditions: Official terms:
Myelodysplastic Syndromes
Study type:
Interventional
Study phase:
Phase 1/Phase 2
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:
TQB3454 Tablets
Description:
TQB3454 Tablets is a selective isocitrate dehydrogenase 1 (IDH1) mutation inhibitor
Arm group label:
TQB3454 Tablets
Summary:
The purpose of this clinical trial is to evaluate the safety of TQB3454 tablets in
patients with acute myeloid leukemia and myelodysplastic syndrome, and determine the
phase II recommended dose.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients voluntarily joined the study and signed informed consent with good
compliance.
- Men and women; The expected survival is ≥3 months.
- Negative serum/urine pregnancy test within 7 days prior to initial dose and must be
non-lactating; Women of childbearing age agree to use contraception (such as an
intrauterine device, birth control pill or condom) during the study and for six
months after the study completion; Men agreed to use contraception during the study
period and for six months after the end of the study.
- The major organs are functioning well;
- For Relapsing/refractory acute myeloid leukemia (AML):
1. According to the classification criteria for Hematopoietic and lymphoid tissue
tumors revised by the World Health Organization (WHO) in 2016, AML confirmed by
bone marrow cell morphology, excluding acute promyelocytic leukemia (APL).
2. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) score is 0~2.
3. Blood biochemical examination:
i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver
infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases; ii: Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and
AST≤5×ULN if liver infiltration was associated.
- For myelodysplastic syndrome (MDS) with higher risk:
1. MDS patients were confirmed by bone marrow cell morphology and cytogenetics and
met the classification criteria of hematopoietic and lymphoid tissue tumors
revised by WHO in 2016.
2. ≥18 years old; ECOG score is 0~2. c. Blood biochemical examination:
i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver
infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases.
ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and
AST≤5×ULN if concomitant with liver infiltration.
Exclusion Criteria:
- Tumor diseases and history:
1. The tumor has or is suspected to involve the central nervous system, or primary
Central nervous system leukemia.
2. Present or present with other malignant tumors within 3 years prior to the
first dose. Except the following conditions: for other malignancies treated
with a single operation, achieving a 5-year continuous disease-free survival
(DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and
superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ),
and T1 (tumor infiltrating basal membrane)].
3. Severe life-threatening complications of leukemia, such as uncontrolled
bleeding, hypoxia or shock pneumonia, and disseminated intravascular
coagulation.
- Previous antitumor therapy:
1. Received National Medical Products Administration (NMPA) approved Chinese
patent drugs with anticancer indications specified in the drug label within 2
weeks prior to initial administration.
2. Toxicities associated with previous antineoplastic therapy did not return to
CTCAE≤1, except for hair loss, fatigue and poor appetite.
3. Associated diseases and history:
1. Abnormal liver.
2. Renal abnormalities.
3. Gastrointestinal abnormalities.
4. Cardio-cerebrovascular abnormalities.
5. Immune-related history.
6. Lung disease.
7. Comorbidities that were severe or poorly controlled and, in the investigator's
judgment, significantly compromised patient safety or hindered study
completion.
8. Risk of bleeding.
- History of drug abuse or drug abuse.
- Participated in clinical trials of other drugs within the past 30 days;
- It is estimated that the patient's compliance to participate in this clinical study
is insufficient.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233000
Country:
China
Status:
Recruiting
Contact:
Last name:
Junfeng Zhu, Master
Phone:
15215526662
Email:
zhujunfeng517@163.com
Facility:
Name:
Cangzhou people's Hospital
Address:
City:
Cangzhou
Zip:
061000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Ma, Bachelor
Phone:
18031798229
Email:
mhm-sspc@163.com
Facility:
Name:
The Affiliated Hospital of Chengde Medical College
Address:
City:
Chengde
Zip:
067000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihua Zhang, Doctor
Phone:
15633142905
Email:
zzhangzhihua@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xundong Wei, Doctor
Phone:
13837169301
Email:
weixudong63@126.com
Facility:
Name:
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Hu, Doctor
Phone:
027-85726685
Email:
dr.huyu@126.com
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Suning Chen, Doctor
Phone:
13814881746
Email:
chensuning@sina.com
Facility:
Name:
Wuxi People's Hospital
Address:
City:
Wuxi
Zip:
214023
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Zhou, Bachelor
Phone:
0510-85350202
Email:
zx89232@126.com
Facility:
Name:
Affiliated Hospital of Binzhou Medical College
Address:
City:
Binzhou
Zip:
264008
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenzheng Yu, Doctor
Phone:
13082727089
Email:
bzywz2009@163.com
Facility:
Name:
Yantai Mountain Hospital
Address:
City:
Yantai
Zip:
264008
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongmei Zhou, Bachelor
Phone:
0535-6863845
Email:
zhoudongmei68@163.com
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Zip:
264008
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoxia Chu, Master
Phone:
18660515179
Email:
lucychu66@163.com
Facility:
Name:
Shanghai Tongren Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ligen Liu, Master
Phone:
18017337037
Email:
Liuligen@medmail.com.cn
Facility:
Name:
Huashan Hospital affiliated to Fudan University
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoqing Wang, Doctor
Phone:
13621851543
Email:
wangxiaoqin@shmu.edu.cn
Facility:
Name:
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200092
Country:
China
Status:
Recruiting
Contact:
Last name:
Siguo Hao, Doctor
Phone:
15301655537
Email:
hosghj88@hotmail.com
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Zip:
200233
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunkang Chang, Master
Phone:
13764643870
Email:
changchunkang7010@aliyun.com
Facility:
Name:
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Address:
City:
Shanghai
Zip:
200437
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenwei Zhu, Doctor
Phone:
18930565525
Email:
wwz3006@163.com
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Guo, Doctor
Phone:
13551321632
Email:
1597949593@qq.com
Facility:
Name:
Hospital of Hematology, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Tiejun Qin, Master
Phone:
13332095356
Email:
qintiejun@ihcams.ac.cn
Start date:
July 10, 2023
Completion date:
December 2025
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/NCT06218771
