RecruitingPhase 2NCT05870995

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

A Phase II Single Arm Study of Cladribine, Cytarabine, Etoposide and Venetoclax Sequential With Reduced Dose Conditioning of Fludarabine, Busulfan and Melphalan or Total Marrow Radiation for Refractory Acute Myeloid Leukemia


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

100 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy combination called CLAGE-Ven (cladribine, cytarabine, gemtuzumab ozogamicin, and venetoclax) followed by a reduced-intensity bone marrow transplant (stem cell transplant) in people with refractory or relapsed acute myeloid leukaemia (AML) — a type of blood cancer — that has not responded to standard treatment. **You may be eligible if...** - You have AML that has not gone into remission after two rounds of chemotherapy, or that has relapsed within 6 months, or has relapsed and not responded to re-induction - You have more than 5% leukaemia cells in your bone marrow - You have a suitable bone marrow donor available (matched sibling, unrelated, or half-matched family donor) - You do not have an active serious infection **You may NOT be eligible if...** - Your liver function or bilirubin levels are significantly abnormal - You do not have a suitable bone marrow donor - You have an active uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCALGE-VEN- RIC-conditioning

Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation


Locations(3)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, China

Department of Hematology, Shanghai No 6 Hospital

Shanghai, China

Shanghai ZhaXin Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT05870995


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