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The purpose of this study is to explore the efficacy and safety of sorafenib combined with venetoclax as pre-emptive therapy strategy for measurable residual disease persisting acute myeloid leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SORA+VEN | Experimental | sorafenib combined with venetoclax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (SORA) | Drug | Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular response rate after three courses of treatment | After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| MRD negative rates after three courses of treatment | MRD negative rates after three courses of treatment | 1 year |
| Cumulative incidence of relapse (CIR) | Will calculate time from hematological complete rate until relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qifa Liu | Contact | +86-020-62787883 | liuqifa628@163.com | |
| Pengcheng Shi | Contact | +86-020-61641615 | shpch283@163.com |
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| Venetoclax (VEN) |
| Drug |
Venetoclax (VEN) was administered at 400mg/day on days 1 to 28. |
|
| 3 year |
| Event-free survival (EFS) | Will calculate time from assignment until relapse or disease progression. | 3 year |
| Overall survival (OS) | Will calculate time from assignment until death from any cause. | 3 year |
| Adverse events (AEs) | Treatment-related AEs were defined as those that occurred from the first dose until 30 days after the discontinuation of treatment. The severity of AEs was graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0, except for haematoloical adverse events. Grade 4 hematological adverse events were defined as either an absolute neutrophil count less than 0.5×10⁹cells per L or a platelet count less than 20×10⁹per L. | 3 year |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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