Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory/relapsed acute myeloid leukemia (R/R AML).
Note: In special circumstances based on the patient's condition, laboratory test indicators, and adverse reactions, etc.; for Venetoclax dosage, if the white blood cell count is >25×10^9/L before administration, hydroxyurea may be given first to reduce the count to less than 25×10^9/L before adding Venetoclax, and then the concentration of Venetoclax will be tested and the dose adjusted according to the concentration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVA | Experimental | Chiglitazar Sodium in combination with Venetoclax and Azacitidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVA | Drug | Chiglitazar Sodium in combination with Venetoclax and Azacitidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate (CR) | The absolute neutrophil count is ≥1.0 × 10^3/μL, the platelet count is ≥1.0 × 10^5/μL, independent of red blood cell transfusions, and the percentage of bone marrow blasts is <5%. There are no circulating bone marrow blasts and blasts with Auer rods in the peripheral blood; no extramedullary disease is present. | Up to 36 months |
| Complete Remission with Incomplete Count Recovery (CRi) | Meeting all CR criteria except for residual neutropenia <1.0 × 10^3/μL (1000/μL) or thrombocytopenia <1.0 × 10^5/μL (100,000/μL). Dependence on red blood cell (RBC) transfusions is also defined as CRi. | Up to 36 months |
| Partial remission rate (PR) | Meets all hematological criteria for CR, but the percentage of blasts in the bone marrow aspirate sample has decreased by at least 50%, reaching between 5% and 25%. | Up to 36 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xu | Contact | 18750918842 | xubingzhangjian@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Xu | The First Aiffiliated hosptical of xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |