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
| Name | Class |
|---|---|
| Jining Medical University | OTHER |
| The Second People's Hospital of Huai'an | OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Venetoclax can significantly improve the remission rate and prolong PFS and OS. At present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly AML patients. It also shows a high response rate in relapsed/refractory AML or MDS patients. There are few clinical studies on the treatment of ALAL. The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed ALAL patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage | Experimental | Venetoclax combined with azacitidine regimen. Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); |
|
| 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 (28 days) induction therapy by venetoclax combined azacitidine regimen. | At the end of Cycle 1 (each cycle is 28 days) |
| Complete Remission Rate (CRR) | The complete remission rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen. | At the end of Cycle 1 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (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 |
| Progression-Free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng-Li Xue, MD | Contact | 0086-0512-67781139 | slxue@suda.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Soochow University | Recruiting | Suzhou | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015456 | Leukemia, Biphenotypic, Acute |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
Not provided
Not provided
Not provided
| Affiliated Hospital of Nantong University |
| OTHER |
| Suzhou Hospital of Traditional Chinese Medicine | OTHER |
| Northern Jiangsu People's Hospital | OTHER |
| Pingdingshan first people's Hospital | UNKNOWN |
| Second Affiliated Hospital of Wannan Medical College | OTHER |
| Canglang Hospital of Suzhou | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| azactidine | Drug | azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 |
|
It is measured from the date of entry into this trial to the date of progression or death. |
| 1 year |
| Adverse events in hematological system | Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction. | 1 year |
| Adverse events in other organs or systems | Record of adverse events in other organs or systems during and after designed venetoclax combined azacitidine regimen induction. | 1 year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |