Clinical Trials in China / NCT07011186
Recruiting
Phase 1/2
A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies
NCT07011186 · tracked via the Priya Life Science China tracker
Condition(s) studied
Myeloid Malignancy
Investigational drug(s) / intervention(s)
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
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
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Official registry record
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.
View NCT07011186 on ClinicalTrials.gov ↗ ← All trials in China