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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3909 Tablets + Azacitidine | Experimental | TQB3909 Tablets administered once-daily. 28 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3909 Tablets + Azacitidine | Drug | TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters | 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) | Up to 24 weeks |
| Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate | Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR) | Proportion of subjects with best response as Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-Free State (MLFS), or Partial Remission (PR) | Up to 4 weeks |
| Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR) |
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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:
Exclusion Criteria:
Comorbidities and Medical History:
Tumor-related Symptoms and Treatment:
Study Treatment-related:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JianXiang Wang, Master | Contact | 13821389157 | wangjx@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Not yet recruiting | Bengbu | Anhui | 233000 | China |
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Proportion of subjects with best response as CR, Morphological Complete Remission (mCR), or PR |
| Up to 4 weeks |
| Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate | Proportion of subjects with best response as CR+CRi. CRi refers to meeting all CR criteria except for residual neutrophil count decrease (ANC < 1.0 × 109/L) or platelet count decrease (PLT < 100 × 109/L). | Up to 4 weeks |
| Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate | Proportion of subjects with best response as CR | Up to 4 weeks |
| Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate | Proportion of subjects with best response as CR | Up to 4 weeks |
| Acute Myeloid Leukemia: Duration of Remission (DOR) | For all subjects with best response as CR, CRi, MLFS, or PR, the time from the first date of achieving remission to the first recorded date of disease progression, relapse, or death (whichever occurs first). | Up to 4 weeks |
| Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh) | For all subjects with best response as CR or CRh, the time from the first date of achieving CR or CRh to the first recorded date of relapse or death (whichever occurs first). | Up to 4 weeks |
| Acute Myeloid Leukemia: Duration of Complete Remission (DOCR) | For all subjects with best response as CR, the time from the first date of achieving CR to the first recorded date of relapse or death (whichever occurs first). | Up to 4 weeks |
| Acute Myeloid Leukemia: Time to First Complete Remission (TTCR) | For all subjects with best response as CR or CRh, the time from the first date of medication to the first date of CR or CRh. | Up to 4 weeks |
| Acute Myeloid Leukemia: Time to First Complete Remission (TTCR) | For subjects with best response as CR, the time from the first date of medication to the first date of CR. | Up to 4 weeks |
| Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS) | Defined as the duration from the first dose of medication to treatment failure, relapse after CR or CRi, or death due to any cause (whichever occurs first). Treatment failure is defined as not achieving CR or CRi at any assessment time during treatment. Subjects with treatment failure will be considered to have an EFS event on the first day after the first dose. For subjects with CR or CRi, the event time will be the time of disease relapse or death (whichever occurs first). | Up to 4 weeks |
| Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS) | The time from the first dose of medication to the date of death due to any cause. | Up to 60 weeks |
| Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate | Proportion of subjects meeting Hematologic Improvement (HI) criteria, including Hematologic Improvement - Erythrocyte (HI-E), Hematologic Improvement - Platelet (HI-P), and Hematologic Improvement - Neutrophil (HI-N). | Up to 4 weeks |
| Myelodysplastic Syndromes: Transfusion Independence Rate | The proportion of subjects who did not require transfusions for at least 56 days after baseline, relative to the number of baseline transfusion-dependent and transfusion-independent subjects. | Up to 8 weeks |
| Beijing Chaoyang Hospital Affiliated to Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
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| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Beijing Tsinghua Changgung Hospital | Not yet recruiting | Beijing | Beijing Municipality | 102218 | China |
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| Affiliated Hospital of Chengde Medical University | Not yet recruiting | Chengde | Hebei | 67020 | China |
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| Harbin The First Hospital | Not yet recruiting | Harbin | Heilongjiang | 150010 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430071 | China |
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| Zhuzhou Central Hospita | Not yet recruiting | Zhuzhou | Hunan | 412007 | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110004 | China |
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| The First Affiliated Hospital of Xi'an Jiao Tong University | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
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| Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center) | Not yet recruiting | Taian | Shandong | 271099 | China |
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| Zibo Central Hospital | Not yet recruiting | Zibo | Shandong | 255036 | China |
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| ShangHai Tongren Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200437 | China |
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| Shanghai Pudong New Area People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 201200 | China |
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| People's hospital of deyang city | Not yet recruiting | Deyang | Sichuan | 618099 | China |
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| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Not yet recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| People's Hospital of Tianjin (City) | Not yet recruiting | Tianjin | Tianjin Municipality | 300122 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| The First Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315010 | China |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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