Actively Recruiting

Phase 2
Age: 16Years - 65Years
All Genders
NCT05870995

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

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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