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| Name | Class |
|---|---|
| The Affiliated Jiangning Hospital of Nanjing Medical University | OTHER |
| Huai'an First People's Hospital | OTHER |
| Yancheng First People's Hospital | OTHER |
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This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia.
This study involves the following:
Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)
This is an open-label, multicenter, phase â…¢ randomized clinical trial to compare the therapeutic efficacy and safety of Venetoclax combined with Decitabine/Azacitidine and Aclarubicin versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia (AML).
The FDA has approved the combination therapy of Venetoclax and Decitabine/Azacitidine for elderly (> 60-year-old) patients with newly diagnosed AML not eligible for intensive chemotherapy. Venetoclax is an inhibitor of BCL-2 (B-cell lymphoma 2, a protein that initiates tumor growth, disease progression, and drug resistance), which can lead to cancer cell death.
Aclarubicin (Acla) is an anthracycline antitumor drug and is a type II topoisomerase Inhibitor that prevents topoisomerase II from binding to DNA primarily by intercalating into DNA strands, resulting in chromatin damage injury without causing DNA damage. In addition to causing chromatin damage, Acla also results in epigenetic inheritance Changes in gene transmission, DNA damage response signals, and apoptosis. Furthermore, in the cytoplasm, Acla can also exert cytotoxic effects by affecting mitochondrial respiratory function. Therefore, Acla is a highly efficient and broad-spectrum chemotherapeutic drug, which is widely used in the treatment of various hematological tumors and solid tumors. In treatment-naive elderly patients with AML, the DCAG (Decitabine-Cytarabine-Aclarubicin-GCSF) regimen can improve the prognosis according to our previous research results. Acla also has relatively mild side effects in the treatment of AML patients.
Participants will be randomly assigned to one of the different treatment groups and followed with consolidated therapy with the same regimen of 2-4 cycles. After completion of study treatment, participants are followed up every 3 months for up to 2 years.
It is expected that about 170 people will take part in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax combined with Decitabine/Azacitidine and Aclarubicin | Experimental | Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes) Aclarubicin (Acla): 10mg/m2 intravenous daily (d1 to d3); |
|
| Venetoclax combined with Decitabine/Azacitidine | Active Comparator | Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax-Decitabine/Azacitidine-Aclarubicin Association | Drug | Treatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi) | CR is defined as absolute neutrophil count > 10^9/ L, platelets > 100×10^9/L, red cell transfusion independence, and bone marrow with < 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of < 10^9/L or platelets < 100×10^9/L. | From randomization to the end of Cycle 1 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Remission (PR) Rate | PR is defined as bone marrow with 5%~25% blasts, at least 50% lower than the initial diagnosis. | From randomization to the end of Cycle 1 (each cycle is 28 days) |
| Overall Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjie Liu, M.D | Contact | +8615895891160 | dreaming88516@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Venetoclax-Decitabine/Azacitidine Association | Drug | Treatment with Venetoclax+Decitabine/Azacitidine |
|
Complete Remission/ Complete Remission with incomplete count recovery/ Partial Remission/ Morphologic Leukemia Free State
| From randomization to the end of Cycle 1 (each cycle is 28 days) |
| Rate of Minimal Residual Disease (MRD) negativity | Percentage of participants who converted to MRD < 10^-3 before initiation of consolidation therapy. MRD is measured by MFC and RT-qPCR. | From randomization to the end of Cycle 1 (each cycle is 28 days) |
| Overall survival (OS) | It is measured from the date of randomization to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive. | From the time of randomization to time for up to 2 years |
| Disease-Free Survival (DFS) | It is defined as the time from the date of CR/CRi to the date of recurrence or death. | From the time of randomization to time for up to 2 years |
| Early Mortality Rate | From the time of randomization to time for up to 2 years |
| Cumulative incidence of relapse (CIR) | It is measured from the date of CR/CRi to the date of relapse. | From the time of CR/CRi to time for up to 2 years |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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