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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
CALGE-VEN- RIC-conditioning
DrugIntensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation
Treatment groups
Trial outcomes
Primary outcomes
disease-free survival (DFS)
patients remain alive in remission without disease progression or relapse
Secondary outcomes
complete remission (CR)
patients achieve clinical remission after transplantation
Overall survival (OS)
patients remain alive
non-relapse mortality (NRM)
patients died without evidence of disease
non-relapse mortality
patients died without evidence of disease
Sponsors and contacts
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