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This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).
This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in newly diagnosed patients with acute myeloid leukemia (AML).
The combination of venetoclax and azacitidine is the standard therapy for elderly (> 60 year old) patients with newly diagnosed AML who are not eligible for intensive chemotherapy. Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. The preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for newly diagnosed young patients with AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 100 patients will take part in this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Induction: Subjects who meet the enrollment conditions will receive Venetoclax plus Azacitidine and CAG(VA-CAG) . Participants will receive this induction Therapy as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission. Consolidation: If patients are intermediate or poor risk and have plans for allogeneic hematopoietic stem-cell transplantation(allo-HSCT) , high dose cytarabine (3g/m2 q12h days 1-3) for 1-2 cycles and follow up with allo-HSCT. In other cases, high dose cytarabine for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax in combination with azacitidine and CAG | Drug | Induction: VA regimen： Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. CAG regimen： Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7; Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7; Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC >20×10^9/L； Consolidation: Drug: Cytarabine 3g/m2 q12h on days 1-3. |
| Measure | Description | Time Frame |
|---|---|---|
| CR rate | At the end of Cycle 1 of induction (each cycle is about 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. | From the first day of induction until the starting day of the next cycle of therapy (up to 60 days） |
| Duration of remission |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall Survival will be defined as the time from administration of the initial doses until death from any cause. | From the first day of induction until the date of death from any cause, assessed up to 30 months |
| Relapse-free survival |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanbin Wang, MD | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Kunming | Yunnan | 650000 | 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 |
|---|---|
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
DOR was defined as the period from the time to acquire CR until relapse |
| From the date of the first remission until the date of relapse (assessed up to 30 months) |
| Minimal Residual Disease negative remission rate (MRD-negative rate) | Percentage of participants who converted to MRD < 10^-3 by flow cytometry before initiation of consolidation therapy. | After 1 cycle of induction (each cycle is about 30 days) |
Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.
| From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |