Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
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
Shanghai Jiao Tong University School of Medicine
100 participants
Feb 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- patients with refractory AML: no remission after 2 induction therapy, relapsed AML within 6 months of 1st CR, relapse AML fail to having CR after reinduction therapy, multiple relapse and refractory relapse AML
- patients with \>5% bone marrow blast by morphology or by LAIP flowcytometry at enrollment
- patients with HLA-matched sibling donor, 9-10/10 matched unrelated donor or haplo-identical family donor
- patients without active infection
- informed consent provided
Exclusion Criteria3
- patients with abnormal liver function (enzyme \>2N or bilirubin \>2N)
- patients with abnormal renal function (Scr \>1.5N)
- patients with poor cardiac function （EF\<45%）
Interventions
Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05870995