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to observe the dose-limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (AML), to explore the maximum tolerated dose (MTD) of the combined D-CMG regimen, and to evaluate its safety and efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-CMG | Experimental | Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes.
Note: Patients who achieve CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-CMG | Drug | Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes.
Note: Patients who achieve CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | Defined as the highest dose at which less than 2 out of 6 (ie. 33%) participants experience a Dose-Limiting Toxicity (DLT). | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CR) | The percent of participants with morphologic complete remission (CR) according to modified International Working Group Acute Myeloid Leukemia Response Criteria (IWG AML) | Up to 24 months |
| Complete Response with incomplete blood count recovery (CRi) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xu | Contact | 18750918842 | xubingzhangjian@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Xu | The First Aiffiliated hosptical of xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Meets all CR criteria, except for residual neutropenia < 1,000/µL or hrombocytopenia < 100,000/µL. Dependence on red blood cell (RBC) transfusions is also defined as CRi. |
| Up to 24 months |
| Disease free survival (DFS) | Applies only to patients who achieve CR or CRi. It is measured from the date of remission to the date of relapse or death from any cause. | Up to 24 months |
| Overall survival (OS) | Time from the start of the patient's initial treatment to the time of death due to any cause. | Up to 24 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |