Myeloid Malignancy
Conditions
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.
Interventions
DRUGTQB3909 Tablets + Azacitidine
TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Acute Myeloid Leukemia (AML): 2. Myelodysplastic Syndromes (MDS) 3. Major organ functions are normal. 4. 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: 1. Diagnosis of or current concomitant malignancy within 3 years prior to the first dose; 2. Presence of multiple factors affecting oral drug intake and/or absorption; 3. Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose; 4. History of arterial/venous thrombotic events within 6 months prior to the first dose; 5. History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders; 6. Presence of any severe and/or uncontrolled disease in the subject. * Tumor-related Symptoms and Treatment: 1. Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN); 2. Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm; 3. Subjects with extramedullary disease only in AML; 4. Presence of life-threatening severe leukemia-related complications; * Study Treatment-related: 1. Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period; 2. Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters | Up to 24 weeks | 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) |
| Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate | Up to 4 weeks | Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate | Up to 4 weeks | 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). |
| Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate | Up to 4 weeks | Proportion of subjects with best response as CR |
| Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate | Up to 4 weeks | Proportion of subjects with best response as CR |
| Acute Myeloid Leukemia: Duration of Remission (DOR) | Up to 4 weeks | 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). |
| Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh) | Up to 4 weeks | 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). |
| Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR) | Up to 4 weeks | 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) |
| Acute Myeloid Leukemia: Time to First Complete Remission (TTCR) | Up to 4 weeks | 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. |
| Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS) | Up to 4 weeks | 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). |
| Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS) | Up to 60 weeks | The time from the first dose of medication to the date of death due to any cause. |
| Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate | Up to 4 weeks | 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). |
| Myelodysplastic Syndromes: Transfusion Independence Rate | Up to 8 weeks | 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. |
| Acute Myeloid Leukemia: Duration of Complete Remission (DOCR) | Up to 4 weeks | 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). |
| Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR) | Up to 4 weeks | Proportion of subjects with best response as CR, Morphological Complete Remission (mCR), or PR |
Countries
China
Contacts
Primary ContactJianXiang Wang, Master
Outcome results
None listed