Actively Recruiting
Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-02-18
100
Participants Needed
3
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with refractory AML, including no remission after 2 induction therapies, relapse within 6 months of first complete remission, failure to achieve remission after reinduction, or multiple/refractory relapse
- Bone marrow blast count greater than 5% by morphology or LAIP flow cytometry at enrollment
- Availability of HLA-matched sibling donor, 9-10/10 matched unrelated donor, or haplo-identical family donor
- No active infection at time of enrollment
- Provided informed consent to participate
You will not qualify if you...
- Abnormal liver function defined as enzyme levels greater than twice normal or bilirubin greater than twice normal
- Abnormal kidney function with serum creatinine greater than 1.5 times normal
- Poor cardiac function with ejection fraction less than 45%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
2
Department of Hematology, Shanghai No 6 Hospital
Shanghai, China
Actively Recruiting
3
Shanghai ZhaXin Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jiong HU
CONTACT
J
Jieling Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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