A Phase 3 interventional study of Venetoclax and Decitabine for Injection in AML, Adult and Chemotherapy Effect, sponsored by Chen Suning. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Chen Suning · Phase 3, Interventional, and Treatment
This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia.
This study involves the following:
Venetoclax and decitabine (investigational combination) Cytarabine and idarubicin (per standard of care)
This is an open-label, multicenter, phase 2 randomized clinical trial to compare the therapeutic efficacy and safety of venetoclax and decitabine to the conventional induction chemotherapy (7+3 regimen) among fit, young adults with newly diagnosed acute myeloid leukemia (AML).
Conventional induction chemotherapy with idarubicin and cytarabine is the standard of induction chemotherapy for acute myeloid leukemia (AML).
The FDA has approved the combination therapy of venetoclax and decitabine 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. Decitabine, a demethylation agent, has the potential to synergically target leukemia stem cell populations when combined with venetoclax as its homologous drug azacytidine.
Participants will be randomly assigned to one of the different induction groups and followed with either consolidation chemotherapy or allogeneic hematopoietic stem cell transplantation after remission. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.
It is expected that about 188 people will take part in this research study.
Chen Suning is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomized participants will receive induction as decitabine on days 1-5 and venetoclax daily on days 1-28. Second Induction (if not reach complete remission, but the percentage of blaste cells in bone marrow decreased by more than 50%):Re-induction with pre-induction therapy. Consolidation: If patients with favorable risk and MRD (Minimal Residual Disease) negative or refuse to allo-HSCT (Hematopoietic stem-cell transplantation), intermediate-dose (2g/m2 q12h days 1-3) for 4 cycles. If patients with intermediate or poor risk or favorable risk but MRD positive, intermediate-dose cytarabine for 1-2 cycles and follow up with allo-HSCT. For patients with FLT3 mutation, gilteritinib can be combined with the follow-up treatment after the end of initial induction.
Drug: Venetoclax · Drug: Decitabine for Injection · Drug: Gilteritinib
Randomized participants will receive cytarabine and idarubicin per standard of care as follows: Induction: cytarabine on days 1-7 and idarubicin (12mg/m2) on days 1-3 . Second Induction (if not reach complete remission, but the percentage of blaste cells in bone marrow decreased by more than 50%): Re-induction with pre-induction therapy. Consolidation: If patients with favorable risk and MRD negative or refuse to allo-HSCT, intermediate-dose cytarabine (2g/m2 q12h days 1-3) for 4 cycles. If patients with intermediate or poor risk or favorable risk but MRD positive, intermediate-dose cytarabine for 1-2 cycles and follow up with allo-HSCT. For patients with FLT3 mutation, gilteritinib can be combined with the follow-up treatment after the end of initial induction.
Drug: Cytarabine · Drug: Idarubicin · Drug: Gilteritinib
Orally by mouth
Also known as: Venclexta
Intravenous infusion
Intravenous infusion
Also known as: Ara-C
Intravenous infusion
Also known as: IDA
Orally by mouth
Also known as: XOSPATA
Overall response rate (ORR)
Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State
Time frame: From randomization to 2 cycles of induction before consolidation therapy（100 days）
Incidence of severe infection (>=grade 3 )
Assessed using CTCAE 5
Time frame: From randomization to 2 cycles of induction before consolidation therapy（100 days）
Duration of myelosuppression
The duration of absolute value of peripheral blood neutrophils \<0.5×10\^9/L and platelet count \<50×10\^9/L during myelosuppression.
Time frame: From randomization to 2 cycles of induction before consolidation therapy（100 days）
Event free survival
Events include progressive disease, relapse, changes in treatment regimens, fatal or intolerable side effects and any death.
Time frame: From the time from randomization to time for up to 2 years
Overall survival
Overall survival
Time frame: From the time from randomization to time for up to 2 years
Rate of Minimal Residual Disease (MRD) negativity
Percentage of participants who converted to MRD \< 10\^-3 before initiation of consolidation therapy.
Time frame: From randomization to 2 cycles of induction before consolidation therapy（100 days）
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Chen Suning