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

NCT06329999 | Recruiting DMC

• 1 other identifier: CMG-sAML-001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mitoxantrone Hydrochloride Liposomes; Cytarabine; Venetoclax; Recurrent Adult Acute Myeloid Leukemia; MDS-EB-2; Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• CRc

  CR (complete remission)+CRi (CR with incomplete recovery of hematological counts)

  1year

Secondary Outcomes (5)

• ORR

  1 year

• OS

  2 year

• RFS

  2 year

• MRD-

  1 year

• Adverse Event

  1 year

Study Arms (1)

CMGV regime

EXPERIMENTAL

Mitoxantrone liposomes，Cytarabine，G-CSF，Venetoclax

Drug: CMGV

Interventions

CMGV DRUG

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.

Also known as: CMGV REGIME

CMGV regime

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
• Age: 18-75 years old (including boundary values of 18 and 75);
• Clinically confirmed adult AML and MDS-IB2 (WHO 2022 standard) patients, AML patients meet any of the following criteria:
• Treatment related AML
• Previously had a history of MDS
• Associated with MDS related genes/chromosomal abnormalities
• Previously had a history of CMML
• Age ≥ 60 years old
• Previous history of prodromal MPN, including ET, PV, and MF, with bone marrow fibrosis ≤ grade 2 (according to the 0-3 grade standard)；
• For elderly AML or MDS patients, the comprehensive evaluation should be based on the Fit population: ECOG\<3, no major comorbidities, and MMSE and SPPB meet the standards (refer to Appendix 8-11);
• Expected survival time ≥ 3 months;
• Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal value (ULN) (≤ 5 times the upper limit of normal value for patients with liver infiltration); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver infiltration); Serum creatinine ≤ 1.5 times the upper limit of normal value;
• The relevant treatment for MDS (excluding blood transfusion) must be completed 2 weeks before the start of the study treatment; In the case of rapidly proliferative diseases, hydroxyurea is allowed to be used until 24 hours before the start of the study treatment. Before starting the research treatment,Toxicity related to previous MDS treatment must be restored to level 2 or below.

You may not qualify if:

• The researchers determined that patients who are not suitable to participate in this study. If a patient meets any of the following criteria, they will not be allowed to enter this study:
• The subject's previous history of anti-tumor treatment meets one of the following conditions:
• Individuals who have previously received mitoxantrone or mitoxantrone liposomes;
• Previously received treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin\>360mg/m2 (1mg of doxorubicin is equivalent to 2mg of doxorubicin or 0.5mg of doxorubicin);
• Within 4 weeks prior to the first use of the study drug or within 5 half-lives of the drug, the patient has received anti-tumor treatment including surgery, chemotherapy, targeted therapy, or participated in other clinical trials and received clinical trial medication;
• Heart function and disease meet one of the following conditions:
• Long QTc syndrome or QTc interval\>480ms;
• Complete left bundle branch block, II or III degree atrioventricular block;
• Severe and uncontrolled arrhythmias that require medication treatment;
• The New York College of Cardiology in the United States has a classification of ≥ II;
• Cardiac ejection fraction (LVEF) below 50%;
• A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to recruitment.
• Patients who have previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated for more than 6 months and have been effectively controlled, as well as patients who have received long-term non chemotherapy treatments such as hormone therapy);
• Uncontrollable systemic diseases (such as infection during the promotion period, uncontrollable hypertension, diabetes, etc.);
• Central nervous system leukemia;

Sponsors & Collaborators

• Ruijin Hospital: lead
• Huadong Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Huashan Hospital: collaborator
• Army Medical Center of PLA: collaborator
• Sun Yat-sen University: collaborator
• RenJi Hospital: collaborator
• Shanghai Jiading District Central Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• First Hospital of China Medical University: collaborator
• Dalian Municipal Central Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shanghai Pudong Hospital: collaborator
• Shanghai Public Health Clinical Center: collaborator
• Xuhui Central Hospital, Shanghai: collaborator
• The Affiliated People's Hospital of Ningbo University: collaborator
• Taizhou First People's Hospital: collaborator
• Wenzhou People's Hospital: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• sujiang Zhang, Doctor

  Hematological Depaement, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqian Xu, Doctor

CONTACT

13816205940; Ellenxxq@qq.com

sujiang Zhang, Doctor

CONTACT

Zbruce.zhang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: February 3, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)