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

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

Conditions

• Recurrent Adult Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Adult Acute Myeloid Leukemia

Interventions

DRUG

CMGV

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.

Sponsors & Collaborators

• Huadong Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Army Medical Center of PLA

  collaborator OTHER_GOV

• Sun Yat-sen University

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shanghai Jiading District Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Dalian Municipal Central Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Shanghai Pudong Hospital

  collaborator OTHER

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Xuhui Central Hospital, Shanghai

  collaborator OTHER

• The Affiliated People's Hospital of Ningbo University

  collaborator OTHER_GOV

• Taizhou First People's Hospital

  collaborator OTHER

• Wenzhou People's Hospital

  collaborator OTHER

• Ruijin Hospital

  lead OTHER

Principal Investigators

• sujiang Zhang, Doctor · Hematological Depaement, Ruijin Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-03

Primary Completion

2025-12-31

Completion

2027-12-31

Countries

• China

Study Locations