A Phase 2 interventional study of Venetoclax；Azacitidine；Homoharringtonine in Secondary Acute Myeloid Leukemia, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Azacitidine and Harringtonine) in patients with secondary AML
This study involves the following:
Venetoclax combined with Azacitidine and Harringtonine
This is an open-label,single center, clinical trial to evaluate the efficacy and safety of Venetoclax in combination with Azacitidine and Harringtonine in patients with sAML
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.
Homoharringtonine (HHT), a plant alkaloid with antitumor properties originally identified nearly 40 years ago, has a unique mechanism of action by preventing the initial elongation step of protein synthesis. HHT has been used widely in China for the treatment of chronic myeloid leukemia (CML), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Participants will receive 1-2 cycles of intensive treatment and followed with consolidated therapy with the same regimen of 4-6 cycles.If CR is not achieved by induction therapy, re-induction therapy can be continued, and those who have not achieved CR after re-induction therapy will withdraw from the study. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) if the patient meets the criteria for transplantation during treatment and a suitable donor exists After completion of study treatment, participants are followed up every 3 months for up to 2 years.
It is expected that about 30 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 30 is below 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.
Patients with acute myeloid leukemia (AML) newly diagnosed by bone marrow morphology and immunophenotyping (in line with the WHO 2016 diagnostic criteria), and meet any of the following conditions:
Exclusion Criteria:
Venetoclax 100mg d1，200mg d2，400mg d3\~d14； Azacitidine 75mg/m2/d，d1\~d7； Homoharringtonine 2mg/d d1\~d7
Drug: Venetoclax；Azacitidine；Homoharringtonine
A cycle every 28 days Treatment with Venetoclax 100mg d1，200mg d2，400mg d3\~d14； Azacitidine 75mg/m2/d，d1\~d7 Homoharringtonine 2mg/d d1\~d7
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 Secondary Outcome Measures: Secondary Outcome Measures: 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
The proportion of allogeneic hematopoietic stem cell transplantation
Proportion of allogeneic hematopoietic stem cell transplantation after disease remission
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
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The First Affiliated Hospital with Nanjing Medical University