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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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The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.
This is a phase 2, open Label, single arm, multi-center study for newly diagnosed T-cell acute lymphoblastic leukemia patients. The patients will receive vanetoclax combined with azacitidine as the induction regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetclax combined with Azacitidine | Experimental | T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax, Azacitidine | 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) |
| 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. | 2 years |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Northern Jiangsu People's Hospital |
| OTHER |
| Affiliated Hospital of Nantong University | OTHER |
| Suzhou Hospital of Traditional Chinese Medicine | OTHER |
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It is measured from the date of entry into this trial to the date of progression or death. |
| 2 years |
| Number of adverse events | Adverse events are evaluated with CTCAE V5.0. | 2 years |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |