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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05177731
Other study ID # SZ-AML02
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 1, 2022
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


Description:

This is an open-label, multicenter, phase Ⅲ randomized clinical trial to compare the therapeutic efficacy and safety of conventional induction chemotherapy (7+3 regimen) to the combination of venetoclax and decitabine 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 consolidated 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 188
Est. completion date December 31, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: 1. Male or female, 59 > =Age (years) >= 18; 2. Newly diagnosed as AML patients according to World Health Organization (WHO) classification; 3. Patients have not received prior therapy for AML (except hydroxyurea and Ara-C<1.0g/d); 4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ; 5. Liver function: Total bilirubin ?3 upper limit of normal (ULN); aspartate aminotransferase (AST) ?3 ULN; alanine aminotransferase (ALT)?3 ULN(except extramedullary infiltration of leukemia) 6. Renal function:Ccr(Creatinine Clearance Rate) ?30 ml/min; 7. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent. Exclusion Criteria: 1. Acute promyeloid leukemia; 2. AML with central nervous system (CNS) infiltration; 3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML; 4. HIV infection; 5. Patients with severe heart failure (grade 3-4) ; 6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal); b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. c) An active second cancer that requires treatment within 6 months of study entry 7. Patients deemed unsuitable for enrolment by the investigator; 8. Patients willing to receive intensive induction chemotherapy 9. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen; 10. Patients reject to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Venetoclax
Orally by mouth
Decitabine for Injection
Intravenous infusion
Cytarabine
Intravenous infusion
Idarubicin
Intravenous infusion
Gilteritinib
Orally by mouth

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Chen Suning

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate (ORR) Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State From randomization to 2 cycles of induction before consolidation therapy(100 days)
Secondary Incidence of severe infection (>=grade 3 ) Assessed using CTCAE 5 From randomization to 2 cycles of induction before consolidation therapy(100 days)
Secondary 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. From randomization to 2 cycles of induction before consolidation therapy(100 days)
Secondary Event free survival Events include progressive disease, relapse, changes in treatment regimens, fatal or intolerable side effects and any death. From the time from randomization to time for up to 2 years
Secondary Overall survival Overall survival From the time from randomization to time for up to 2 years
Secondary Rate of Minimal Residual Disease (MRD) negativity Percentage of participants who converted to MRD < 10^-3 before initiation of consolidation therapy. From randomization to 2 cycles of induction before consolidation therapy(100 days)
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