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Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
The investigators developed a protocol combining chemotherapy of cladribine, cytarabine and etoposide (CLAGE) as debulking treatment sequential with reduced intensity conditioning regimen Flu-Bu to treat patients with refractory acute myeloid leukemia (AML). In this study, the aim is to further evaluate the efficacy and feasibility of the protocol with modifications: 1) reduced dose of CLAGE; 2) Reduced intensity conditioning (RIC) regimen as fludarabine, busulfan and melphalan (MBF) or total marrow irradiation (TMI); 3) Venetoclax was added to the chemotherapy and conditioning regimen.
Official title: A Phase II Single Arm Study of Cladribine, Cytarabine, Etoposide and Venetoclax Sequential With Reduced Dose Conditioning of Fludarabine, Busulfan and Melphalan or Total Marrow Radiation for Refractory Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-02-01
Completion Date
2026-09-01
Last Updated
2025-02-18
Healthy Volunteers
No
Conditions
Interventions
CALGE-VEN- RIC-conditioning
Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation
Locations (3)
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China
Department of Hematology, Shanghai No 6 Hospital
Shanghai, China
Shanghai ZhaXin Hospital
Shanghai, China