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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • CALGE-VEN- RIC-conditioning

    Drug

    Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: CLAGE-VEN-RIC-ConditioningExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

disease-free survival (DFS)

patients remain alive in remission without disease progression or relapse

Time frame
2 year

Secondary outcomes

1

complete remission (CR)

patients achieve clinical remission after transplantation

Time frame
day 60
2

Overall survival (OS)

patients remain alive

Time frame
2 year
3

non-relapse mortality (NRM)

patients died without evidence of disease

Time frame
day 100
4

non-relapse mortality

patients died without evidence of disease

Time frame
2 year

Other outcomes

Sponsors and contacts

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