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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-65
SponsorShanghai Jiao Tong University School of Medicine

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

Treatment groups

100 Participants
are divided into 1 treatment group