RecruitingNot ApplicableNCT06329999

A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML

A Prospective, Multicenter, and Exploratory Study of Mitoxantrone Liposomes, Cytarabine and G-CSF Combined With Vineclavone in the Treatment ofRecurrent Adult AML and MDS-EB-2/Elder AML


Sponsor

Ruijin Hospital

Enrollment

78 participants

Start Date

Feb 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial\] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia\]. The main questions it aims to answer are: * Evaluation of the efficacy * Evaluation of the safety


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called CMGV in people with relapsed or hard-to-treat acute myeloid leukemia (AML) — a cancer of the blood and bone marrow — or a related condition called MDS with excess blasts type 2. This trial focuses on patients who are older or whose AML has specific features that make it more difficult to treat with standard therapies. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with AML or MDS with high-risk features (such as treatment-related AML, prior MDS, specific genetic/chromosomal abnormalities, prior chronic blood disorders, or age 60 and older) - You are in generally good health (able to function independently, no major organ problems) - Your expected survival is at least 3 months - Your liver and kidney function meet required levels **You may NOT be eligible if:** - You are in very poor general health (ECOG score of 3 or more) or have major medical conditions - Your liver or kidney function is significantly impaired - You have an active serious 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

DRUGCMGV

Initial treatment induction therapy: CMG+Vineclavone regimen Mitoxantrone liposomes 15mg/m2, iv, d1; Cytarabine 10mg/m2, H, q12h, d1-7; G-CSF starts at 5ug/kg, H, d0, WBC ≥ 30 × 109/L, stop G-CSF; Vinecla 100mg, 2200mg, 3400mg, d4-10. Every 4 weeks is a cycle, for a total of 2 cycles. For patients with CR/CRI/MLFS/PR in the first cycle, repeat this regimen for consolidation treatment once (the second course of treatment is Vineclavone 400mg d1-7). Follow up treatment: Patients who meet the transplantation criteria will undergo hematopoietic stem cell transplantation, while those who do not undergo transplantation will continue to receive CMG+Vineclavone consolidation for 4-6 courses.


Locations(1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

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NCT06329999


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