TQB3909 Tablets + Azacitidine: TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue
Study summary
This is an open, multi-center clinical study designed to evaluate the safety, tolerability and efficacy of TQB3909 tablets in combination with azacitidine in subjects with myeloid malignancies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Voluntary and signed informed consent, good compliance
* Age: ≥18 years old (at the time of signing the informed consent); expected survival time greater than 3 months.
* Diagnosis of one of the following diseases:
1. Acute Myeloid Leukemia (AML):
2. Myelodysplastic Syndromes (MDS)
3. Major organ functions are normal.
4. Fertile male and female subjects agree to use contraception during the study and for 6 months after the study ends.
Exclusion Criteria:
* Comorbidities and Medical History:
1. Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
2. Presence of multiple factors affecting oral drug intake and/or absorption;
3. Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
4. History of arterial/venous thrombotic events within 6 months prior to the first dose;
5. History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders;
6. Presence of any severe and/or uncontrolled disease in the subject.
* Tumor-related Symptoms and Treatment:
1. Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN);
2. Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm;
3. Subjects with extramedullary disease only in AML;
4. Presence of life-threatening severe leukemia-related complications;
* Study Treatment-related:
1. Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period;
2. Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.
Primary outcome measure(s)
Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters — Up to 24 weeks Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever occurs first)
Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate — Up to 4 weeks Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Trial sites (21)
Facility
City
Region
Status
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Anhui
Not Yet Recruiting
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing
Beijing Municipality
Not Yet Recruiting
Peking University People's Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Affiliated Hospital of Chengde Medical University
Chengde
Hebei
Not Yet Recruiting
Harbin The First Hospital
Harbin
Heilongjiang
Not Yet Recruiting
Henan Provincial People's Hospital
Zhengzhou
Henan
Not Yet Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Hubei
Not Yet Recruiting
Zhuzhou Central Hospita
Zhuzhou
Hunan
Not Yet Recruiting
Shengjing Hospital of China Medical University
Shenyang
Liaoning
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an
Shaanxi
Not Yet Recruiting
Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center)
Taian
Shandong
Not Yet Recruiting
Zibo Central Hospital
Zibo
Shandong
Not Yet Recruiting
ShangHai Tongren Hospital
Shanghai
Shanghai Municipality
Recruiting
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanghai Pudong New Area People's Hospital
Shanghai
Shanghai Municipality
Not Yet Recruiting
People's hospital of deyang city
Deyang
Sichuan
Not Yet Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin
Tianjin Municipality
Not Yet Recruiting
People's Hospital of Tianjin (City)
Tianjin
Tianjin Municipality
Not Yet Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
Not Yet Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo
Zhejiang
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.