Actively Recruiting
A Phase Ib/II 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 Ib/II 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive TQB3909 Tablets once daily in combination with Azacitidine in repeated 28-day cycles.
Regular visits during treatment cycles
Duration - Up to 36 weeks following treatment
Participants are monitored for safety and survival after treatment ends.
Periodic visits for up to 36 weeks
Trial Site Locations
Total: 21 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233000
Not Yet Recruiting
2
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100020
Not Yet Recruiting
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
4
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Not Yet Recruiting
5
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China, 67020
Not Yet Recruiting
6
Harbin The First Hospital
Harbin, Heilongjiang, China, 150010
Not Yet Recruiting
7
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
8
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Not Yet Recruiting
9
Zhuzhou Central Hospita
Zhuzhou, Hunan, China, 412007
Not Yet Recruiting
10
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
11
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
12
Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center)
Taian, Shandong, China, 271099
Not Yet Recruiting
13
Zibo Central Hospital
Zibo, Shandong, China, 255036
Not Yet Recruiting
14
ShangHai Tongren Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
15
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
Shanghai, Shanghai Municipality, China, 200437
Not Yet Recruiting
16
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality, China, 201200
Not Yet Recruiting
17
People's hospital of deyang city
Deyang, Sichuan, China, 618099
Not Yet Recruiting
18
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
19
People's Hospital of Tianjin (City)
Tianjin, Tianjin Municipality, China, 300122
Not Yet Recruiting
20
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
21
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Not Yet Recruiting
Research Team
J
JianXiang Wang, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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