Actively Recruiting
A Prospective, Multicenter, and Exploratory Study of Mitoxantrone Liposomes, Cytarabine and G-CSF Combined With Venetoclax 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
104 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
H
Huadong Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving mitoxantrone hydrochloride liposomes, subcutaneous cytarabine, G-CSF, and Venetoclax (CMG+Ven) for adults with secondary acute myeloid leukemia (AML) or myelodysplastic syndrome with increased primordial cells type 2 (MDS-IB2), as well as elderly AML patients. The study aims to assess the treatment's effectiveness and safety in these recurrent or difficult-to-treat cases. Mitoxantrone is a chemotherapy drug that interferes with DNA and RNA, and this study explores a new liposomal form developed in China. The treatment includes an induction phase with mitoxantrone liposomes given intravenously, cytarabine injected subcutaneously twice daily for seven days, G-CSF injections starting one day before treatment, and oral Venetoclax given on days 4 to 10. Each treatment cycle lasts four weeks, with two cycles planned initially. Patients who respond well may receive an additional consolidation cycle or proceed to stem cell transplantation if eligible, while others continue consolidation therapy for several more cycles. Participants will undergo regular evaluations including clinical assessments, laboratory tests, and monitoring for side effects. The main outcome measured is the complete remission rate within one year. Additional outcomes monitored include overall response rate, survival, relapse-free survival, minimal residual disease levels, and adverse events over one to two years. The total study duration covers initial treatment, follow-up, and monitoring until the planned end date in 2027.
CONDITIONS
Brief 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 voluntarily agrees to participate and signs informed consent
- Age between 18 and 75 years inclusive
- Clinically confirmed adult AML or MDS-IB2 diagnosis per WHO 2022 standards
- AML patients meeting criteria such as treatment-related AML, history of MDS or CMML, MDS-related genes or chromosomal abnormalities, age 60 or older, or prior prodromal MPN with bone marrow fibrosis grade 2 or less
- Elderly AML or MDS patients must be fit based on ECOG <3, no major comorbidities, and meet MMSE and SPPB standards
- Expected survival time of at least 3 months
- Liver and kidney function within specified limits
- Completion of relevant MDS treatment at least 2 weeks before study start with toxicity restored to level 2 or below
You will not qualify if you...
- Prior treatment with mitoxantrone or mitoxantrone liposomes
- Previous doxorubicin or anthracycline treatment exceeding cumulative dose limits
- Anti-tumor treatment within 4 weeks before study drug or participation in another trial with clinical trial medication recently
- Heart conditions including long QTc syndrome, severe arrhythmias, left bundle branch block, low ejection fraction, recent myocardial infarction or unstable angina
- History or current other malignant tumors except certain controlled types
- Uncontrollable systemic diseases like active infection, hypertension, or diabetes
- Central nervous system leukemia
- Bone marrow fibrosis grade 3 or higher in secondary AML
- Sudden changes in chronic myeloid leukemia
- Acute promyelocytic leukemia or certain chromosome karyotypes indicating well prognosis
- HIV infection or active hepatitis B or C infection beyond specified viral load
- Known severe hypersensitivity to study drugs or excipients
- Severe neurological or mental illness
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 months depending on response and treatment plan
Participants receive initial treatment induction therapy with CMGV regimen consisting of Mitoxantrone liposomes, Cytarabine, G-CSF, and Venetoclax in cycles. Those who respond after the first cycle receive a consolidation treatment cycle. Follow-up treatments include hematopoietic stem cell transplantation for eligible participants or continued CMGV consolidation for 4 to 6 courses for those not undergoing transplantation.
Every 4 weeks for up to 2 cycles of induction and additional consolidation cycles as needed
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiaoqian Xu, Doctor
S
sujiang Zhang, Doctor
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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