Status:
RECRUITING
A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Myeloid Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
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:
- 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.
Exclusion Criteria:
-
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.
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT07011186
Start Date
April 17 2024
End Date
October 1 2026
Last Update
June 8 2025
Active Locations (21)
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1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233000
2
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100020
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
4
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218