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This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon Group | Experimental | Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months. |
|
| Control Group | No Intervention | Observational follow-up without receiving any maintenance treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon | Drug | Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month negative conversion of MRD | MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative. | Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| CIR | The number of patients with relapse calculated from the randomization time to the last follow-up time. | Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years. |
| EFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feifei Tang, Prof | Contact | 13581671687 | bjmugirl@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | 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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| ID | Term |
|---|---|
| D007372 | Interferons |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Events include treatment failure (MRD positivity or molecular progression), relapse, or death from any cause.
| Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years. |
| OS | calculated from randomization time to the time of death or the last follow-up time. | Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years. |
| Treatment-related Safety Indicators | Mainly include hematologic toxicity and liver toxicity. | Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |