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RECRUITING
NCT05870995
PHASE2

Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

Interventions

DRUG

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