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Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
Official title: Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial
Key Details
Gender
All
Age Range
60 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2023-10-01
Completion Date
2028-05-10
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Different induction chemotherapy regimens
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
Locations (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, China