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
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D/IA (Daunorubicin/Idarubicin + Cytarabine) | Active Comparator | Induction Cycle 1:
Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Maintenance Therapy
VA Regimen, 6 cycles Allogeneic Transplantation: Recommended for high-risk patients and those with persistent MRD positivity. |
|
| VA Regimen | Experimental | Induction Cycles
Day 1: 100 mg Day 2: 200 mg Days 3-21: 400 mg/day If bone marrow blasts >5% on day 21, extend to day 28 with 400 mg/day • Efficacy will be assessed after 2 cycles. If CR/CRi/CRh is not achieved but the investigator believes continued treatment is beneficial, up to 4 cycles may be administered. Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Maintenance Therapy
Allogeneic Transplantation: Recommended for high-risk patients and those with persistent MRD positivity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daunorubicin/Idarubicin | Drug | Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization to death from any cause. | up to 1 years after completion of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission Rate (CR/CRh/CRi) | Proportion of patients achieving CR, CRh, or CRi after induction. | Six weeks after induction therapy |
| MRD Negativity Rate | Proportion of patients achieving MRD negativity after induction and overall treatment. |
Not provided
Inclusion Criteria:
Diagnosis of AML according to WHO (2022) or ICC criteria.
Age ≥55 and ≤75 years.
ECOG performance status score of 0-2.
Adequate organ function:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Wei, MD | Contact | 13132507161 | weihui@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hui Wei, MD | Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Diseases Hospital | Recruiting | Tianjin | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D015255 | Idarubicin |
| D003561 | Cytarabine |
| D001374 | Azacitidine |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cytarabine | Drug | Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy. |
|
| Azacitidine | Drug | Azacitidine is used in VA regimen |
|
| Venetoclax | Drug | Venetoclax is used in VA regimen |
|
| up to 1 years after completion of enrollment |
| Relapse-Free Survival (RFS) | Time from achieving CR/CRh/CRi to relapse or death. | up to 1 years after completion of enrollment |
| Event-Free Survival (EFS) | Time from randomization to treatment failure, relapse, or death. | up to 1 years after completion of enrollment |
| 30-Day and 60-Day Mortality Rates | Proportion of patients who die within 30 and 60 days of starting treatment. | within 30 and 60 days of starting treatment. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D001372 | Aza Compounds |
| D012263 | Ribonucleosides |