A Phase 3 interventional study of Venetoclax-Decitabine/Azacitidine-Aclarubicin Association and Venetoclax-Decitabine/Azacitidine Association in Acute Myeloid Leukemia, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-30.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 3, Interventional, and Treatment
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 Ⅲ 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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 170 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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);
Drug: Venetoclax-Decitabine/Azacitidine-Aclarubicin Association
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)
Drug: Venetoclax-Decitabine/Azacitidine Association
Treatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin
Treatment with Venetoclax+Decitabine/Azacitidine
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.
Time frame: From randomization to the end of Cycle 1 (each cycle is 28 days)
Partial Remission (PR) Rate
PR is defined as bone marrow with 5%\~25% blasts, at least 50% lower than the initial diagnosis.
Time frame: From randomization to the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate (ORR)
Complete Remission/ Complete Remission with incomplete count recovery/ Partial Remission/ Morphologic Leukemia Free State
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the time of randomization to time for up to 2 years
Early Mortality Rate
Time frame: 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.
Time frame: From the time of CR/CRi to time for up to 2 years
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital with Nanjing Medical University