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This study is to assess the efficacy and safety of Lisaftoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisaftoclax for Prevention of Differentiation Syndrom | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisaftoclax (APG-2575) | Drug | Description: Newly diagnosed APL patients receive standard induction therapy with oral ATRA 25 mg/m²/day and intravenous ATO 0.16 mg/kg/day. Lisaftoclax (APG-2575) is given for DS prophylaxis in patients with peripheral WBC count >2.0×10⁹/L or ≥24-hour 2-fold WBC elevation. Lisaftoclax can only be initiated 24 hours after ATRA/ATO induction initiation. Dosing and Escalation: Lisaftoclax starts at 50 mg QD. Dose may be escalated to 100 mg QD, with a maximum dose of 100 mg twice daily (bid) based on patient tolerability. Monitoring and Interruption: Daily peripheral blood count monitoring is required during Lisaftoclax treatment. Lisaftoclax must be immediately withheld if the WBC count declines for two consecutive days. Protocol-defined dexamethasone or ruxolitinib will be administered for suspected DS during induction therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of Differentiation Syndrom | DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure. | the induction regimen (21 days to 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaojiao Yuan | Contact | 86+15257498577 | 1142510531@qq.com |
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| ID | Term |
|---|---|
| D015473 | Leukemia, Promyelocytic, Acute |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000726452 | Lisaftoclax |
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|
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |