Actively Recruiting
Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia
Led by Hui Zeng · Updated on 2022-08-30
70
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
Sponsors
H
Hui Zeng
Lead Sponsor
C
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, single-arm, phase I/II clinical study. Phase I is a multi-center, dose-escalation study, aiming to explore the maximum tolerated dose (MTD) of venetoclax combined with mitoxantrone liposome in the treatment of relapsed or refractory acute myeloid leukemia (AML), and determine the recommended dose for phase II (RP2D); Phase II is a multi-center, exploratory study, aiming to explore efficacy of venetoclax combined with mitoxantrone liposome in the treatment of relapsed and refractory AML patients, and to explore the differences in the efficacy of this combination therapy with different gene mutations.
CONDITIONS
Official Title
Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- AML confirmed by bone marrow cytology and pathology
- Diagnosed with relapsed or refractory AML based on specific clinical criteria
- ECOG performance status between 0 and 2
- Liver function: AST and ALT 2.5 times ULN (up to 5 times with liver infiltrates); total bilirubin 1.5 times ULN (up to 3 times with liver infiltrates)
- Kidney function: serum creatinine 1.5 times ULN
- Normal cardiac function with LVEF 45% by echocardiography or radionuclide angiography
- Pulmonary function: dyspnea grade 1 or less and oxygen saturation 92% on room air
- Expected survival longer than 3 months
- Voluntary participation with informed consent signed
You will not qualify if you...
- Previous treatment with mitoxantrone or mitoxantrone liposome
- Prior doxorubicin or other anthracycline treatment exceeding cumulative dose of 360 mg/m2 doxorubicin equivalent
- Anti-tumor therapy or participation in other clinical trials within 4 weeks before study drug
- Heart conditions including long QTc syndrome (QTc > 480 ms), high-grade heart blocks, serious arrhythmias, NYHA class II or higher heart failure, recent myocardial infarction or unstable angina
- Central nervous system leukemia involvement
- Other active cancers except certain controlled non-melanoma skin and in situ breast or cervical cancers
- Uncontrolled systemic diseases such as infections, hypertension, or diabetes
- HIV infection
- Active hepatitis B or C infections with viral load above set thresholds
- Allergy to study drugs or components
- Pregnancy or breastfeeding, or refusal to use effective contraception
- Serious neurological or psychiatric history
- Investigator judgment deeming participant unsuitable for study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510632
Actively Recruiting
Research Team
H
Hui Zeng, M.D
CONTACT
H
Huien Zhan, M.M.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here