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

Myelodysplastic Syndrome Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Mitoxantrone is a traditional anthracycline drug. It exerts anti-tumor effects by interfering with DNA, RNA and inhibiting topoisomerase II. It is a cell cycle non-specific drug ; Mitoxantrone has been used in AML patients. It is widely used in both induction and relapse and refractory treatment stages . At the same time, the literature shows that there is no complete cross-resistance between mitoxantrone and other anthracycline drugs, and it is still effective for patients who have relapsed after previous first-line anthracycline treatment . In addition, the CMG (standard dose cytarabine + mitoxantrone + G-CSF) prestimulation regimen has many applications in China ; a study showed that 16 cases of elderly AML (50% were early in the elderly The CR rate of the CMG regimen for the treatment of secondary AML was 50%, the ORR was 87.4%, and the median OS was 12 months in 2006; a study applied the CMG regimen vs. the conventional dose MA regimen (mitoxantrone + arabinoside Glucoside) in the treatment of elderly AML, the results showed that there was no significant difference in efficacy between the two regimens, but the CMG group had a shorter bone marrow suppression period and less bleeding and infection than the MA group in 2014. Since there is no drug for mitoxantrone in the domestic market for a long period of time, its clinical application is limited. Mitoxantrone Hydrochloride Liposomal Injection is a Class 2 new drug independently developed by CSPC. It will be launched in China in 2022. The approved indications are: those who have received at least first-line standard treatment (including chemotherapy, autologous hematopoietic stem cell transplantation, etc.) For patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), the registration key phase II clinical trial showed good therapeutic effects in relapsed or refractory PTCL and NKTCL, with a confirmed ORR of 41.7%; among them, NKTCL subtype The type has remarkable efficacy, breaking through the limitations of NKTCL's natural resistance to anthracyclines in previous clinical experience. The ORR of single-drug treatment can reach 42.9%. ;

Related Conditions & MeSH terms

• Adult Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Recurrence
• Recurrent Adult Acute Myeloid Leukemia

• NCT number: NCT06329999
• Study type: Interventional
• Source: Ruijin Hospital
• Contact: Xiaoqian Xu, Doctor
• Phone: 13816205940
• Email: Ellenxxq@qq.com
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2024
• Completion date: December 31, 2027