Actively Recruiting
A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML
Led by Ruijin Hospital · Updated on 2024-03-26
78
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
H
Huadong Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient understands the study, agrees voluntarily, and signs consent
- Age between 18 and 75 years
- Clinically confirmed adult AML or MDS-IB2 according to WHO 2022 criteria
- AML diagnosis meets any of these: treatment-related, history of MDS or CMML, MDS-related genetic abnormalities, age 60 or older, or history of certain myeloproliferative neoplasms with mild bone marrow fibrosis
- For elderly AML or MDS, fit patients with ECOG less than 3 and suitable cognitive and physical status
- Expected survival time of at least 3 months
- Liver and kidney function within specified normal limits
- Completed relevant MDS treatment at least 2 weeks before study start, with toxicity resolved to level 2 or below
You will not qualify if you...
- Previous treatment with mitoxantrone or mitoxantrone liposomes
- Prior doxorubicin or anthracycline treatment exceeding cumulative dose limits
- Anti-tumor treatment or clinical trial medication within 4 weeks or 5 drug half-lives before study drug
- Heart conditions including long QTc, severe arrhythmias, low ejection fraction, or recent major cardiac events
- History or current other malignant tumors except some controlled cases
- Uncontrollable systemic diseases like active infections or uncontrolled hypertension or diabetes
- Central nervous system leukemia
- Bone marrow fibrosis grade 3 or higher in secondary AML
- Sudden changes in chronic myelogenous leukemia
- Certain favorable chromosome abnormalities or acute promyelocytic leukemia
- HIV positive or active hepatitis B or C infections exceeding viral load thresholds
- Known severe allergic reactions to study drugs or ingredients
- Severe neurological or mental illness
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiaoqian Xu, Doctor
CONTACT
S
sujiang Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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