Actively Recruiting
A Phase IbII Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of TQB3909 Tablets in Combination With Azacitidine in Subjects With Myeloid Malignancies
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-06-08
138
Participants Needed
21
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of TQB3909 tablets combined with azacitidine in adults with myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndromes. This open, multi-center clinical trial is designed as a Phase IbII study to better understand how this combination treatment works in these blood cancers. Participants receive TQB3909 tablets once daily in 28-day treatment cycles along with azacitidine. The study focuses on monitoring how well patients tolerate the treatment and its effects on their disease. The trial includes assessment of various response rates and survival outcomes over several weeks. Throughout the trial, participants undergo regular evaluations including monitoring for adverse events and laboratory tests for up to 24 weeks. Researchers measure remission rates, duration of remission, and survival outcomes up to 60 weeks. Participants safety and response to treatment are closely tracked during the study.
CONDITIONS
Brief Title
A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary and signed informed consent with good compliance
- Age 18 years or older at the time of consent
- Diagnosed with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
- Normal major organ function
- Fertile men and women agree to use contraception during the study and for 6 months after completion
You will not qualify if you...
- Diagnosis of or current concomitant malignancy within 3 years prior to first dose
- Factors affecting oral drug intake or absorption
- Major surgery or significant trauma within 28 days prior to first dose
- History of arterial or venous thrombotic events within 6 months prior to first dose
- History of psychiatric drug abuse that cannot be stopped or psychiatric disorders
- Severe or uncontrolled diseases
- Diagnosis of Acute Promyelocytic Leukemia (APL) or MDS/MPN
- Leukemia central nervous system involvement or suspected but unconfirmed
- Extramedullary disease only in AML
- Life-threatening severe leukemia complications
- Received live vaccines within 4 weeks prior to first dose or planned during study
- Participation in other anti-tumor drug clinical trials within 4 weeks prior to first dose
Research Team
J
JianXiang Wang, Master
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