A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies
Recruiting now · Phase 1/Phase 2
Conditions studied: Myeloid Malignancy
In brief
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.
Key facts
- Study ID
- NCT07011186
- Run by
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- People needed
- 138
- Starts
- 2024-04-17
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Acute Myeloid Leukemia (AML):
- Myelodysplastic Syndromes (MDS)
- Major organ functions are normal.
- Fertile male and female subjects agree to use contraception during the study and for 6 months after the study ends.
You may not qualify if…
- Comorbidities and Medical History:
- Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
- Presence of multiple factors affecting oral drug intake and/or absorption;
- Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
- History of arterial/venous thrombotic events within 6 months prior to the first dose;
- History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders;
- Presence of any severe and/or uncontrolled disease in the subject.
- Tumor-related Symptoms and Treatment:
- Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN);
- Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm;
- Subjects with extramedullary disease only in AML;
- Presence of life-threatening severe leukemia-related complications;
- Study Treatment-related:
- Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period;
- Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.
Where it is running
- ShangHai Tongren Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Beijing Chaoyang Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China
- Peking University People's Hospital — Beijing, Beijing Municipality, China
- Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China
- Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China
- Harbin The First Hospital — Harbin, Heilongjiang, China
- Henan Provincial People's Hospital — Zhengzhou, Henan, China
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China
- Zhuzhou Central Hospita — Zhuzhou, Hunan, China
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
- The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shaanxi, China
- Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center) — Taian, Shandong, China
- Zibo Central Hospital — Zibo, Shandong, China
- Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital — Shanghai, Shanghai Municipality, China
- Shanghai Pudong New Area People's Hospital — Shanghai, Shanghai Municipality, China
- People's hospital of deyang city — Deyang, Sichuan, China
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, Tianjin Municipality, China
- People's Hospital of Tianjin (City) — Tianjin, Tianjin Municipality, China
- The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China
- The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China
- The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China
Full record on ClinicalTrials.gov
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