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| Name | Class |
|---|---|
| Jining Medical University | OTHER |
| The Second People's Hospital of Huai'an | OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
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This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetclax combined with azacitidine | Experimental | Relapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax combined with azacitidine regimen treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax combined with azacitidine regimen | Drug | Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 . |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen. | At the end of Cycle 1 (each cycle is 21 days) |
| Complete Remission Rate (CRR) | The complete remission rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen. | At the end of Cycle 1 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survial (OS) | It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive. | 1 year |
| Relapse-Free Survival (RFS) |
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Inclusion Criteria:
Patients aged ≥ 15 and ≤ 70 years.
Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
Patients with T-ALL/LBL must meet one of the following criteria, A or B.
A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.
B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.
ECOG performance status score less than 3.
Expected survival time >3 months.
Patients without serious heart, lung, liver, or kidney disease.
Ability to understand and voluntarily provide informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41338863 | Derived | Cao HY, Zhang H, Zhang Y, Hu XH, Yang L, Yang YL, Zhang YM, Wu B, Huang ZQ, Huang R, Wang RJ, Wan CL, Wu DP, Dai HP, Xue SL. Venetoclax plus azacitidine in relapsed or refractory T-cell acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Dec;12(12):e946-e955. doi: 10.1016/S2352-3026(25)00284-4. |
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| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| Affiliated Hospital of Nantong University |
| OTHER |
| Suzhou Hospital of Traditional Chinese Medicine | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Southern Medical University, China | OTHER |
| Nanyang Central Hospital of Henan Province | UNKNOWN |
| Canglang Hospital of Suzhou | UNKNOWN |
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It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause. |
| 1 year |
| Adverse events in hematological system | Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction. | 1 month |
| Adverse events in other organs or systems | Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction. | 1 month |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |