Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
Recruiting now · Phase 2
Conditions studied: Refractory Leukemia
In brief
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.
Key facts
- Study ID
- NCT05870995
- Run by
- Shanghai Jiao Tong University School of Medicine
- People needed
- 100
- Starts
- 2023-02-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-02-18
Who can join
Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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%）
Where it is running
- Blood & Marrow Transplantation Center, RuiJin Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Department of Hematology, Shanghai No 6 Hospital — Shanghai, China (enrolling)
- Shanghai ZhaXin Hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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