About this trial
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 criteria
Qualifiers
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
Disqualifiers
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%)
Trial design
Treatments tested in this trial
- CALGE-VEN- RIC-conditioning