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

RECRUITINGPhase 2Sponsored by Shanghai Jiao Tong University School of Medicine
Actively Recruiting
PhasePhase 2
SponsorShanghai Jiao Tong University School of Medicine
Started2023-02-01
Est. completion2026-02-01
Eligibility
Age16 Years – 65 Years
Healthy vol.Accepted

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

Age: 16 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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%)

Conditions2

CancerRefractory Leukemia

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