Chemotherapy Effect Clinical Trial
Official title:
Comparing the Efficacy and Safety of Venetoclax Combined With Decitabine Versus Conventional "7+3" Induction Chemotherapy of Acute Myeloid Leukemia in Young Adults
Verified date | June 2024 |
Source | The First Affiliated Hospital of Soochow University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Chen Suning |
China,
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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