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The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZA+VEN | Experimental | Azacitidine combined with venetoclax as induction regimen |
|
| DA/IA 3+7 | Active Comparator | Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen |
|
| DA/IA 2+5+VEN | Experimental | Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Different induction chemotherapy regimens | Other | azacitidine combined with venetoclax or chemotherapy with or without venetoclax |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first). | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day postinduction mortality | It is defined as death from any cause within 30 days after the start of induction. | Up to approximately 30 days |
| Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Wei, MD | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | 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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Proportion of patients with CR, CRh or CRi |
| Up to approximately eight weeks |
| Minimal residual disease (MRD)-negative remission rates after induction | Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative | Up to approximately eight weeks |
| Cumulative incidence of minimal residual disease (MRD)-negative remission rates | The proportion of patients with negative MRD results at any time during treatment | Up to approximately 1 years |
| Relapse-free Survival (RFS) | It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up. | Up to approximately 2 years |
| Overall survival (OS) | It is defined as the time from the start of randomization to the death from any cause. | Up to approximately 2 years |
| 60-day postinduction mortality | It is defined as death from any cause within 60 days after the start of induction. | Up to approximately 60 days |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |