Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute
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 an
| Condition(s) | Refractory Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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%） |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Lead sponsor | Shanghai Jiao Tong University School of Medicine |
| Locations | Shanghai, Shanghai Municipality, China; Shanghai, China; Shanghai, China |
| Start date | 2023-02-01 |
| NCT ID | NCT05870995 |
| Official listing | https://clinicaltrials.gov/study/NCT05870995 |