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Trial Title:
Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia
NCT ID:
NCT05522192
Condition:
Relapsed or Refractory Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Venetoclax
Mitoxantrone
Conditions: Keywords:
venetoclax; Mitoxantrone liposomes; Acute myeloid leukemia
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mitoxantrone liposome
Description:
Phase I: 24mg/m2, 30 mg/m2, 36mg/m2, IV, d1; Phase II: RP2D.
Arm group label:
Venetoclax-Mitoxantrone liposome
Other name:
Mitoxantrone Hydrochloride Liposome Injection
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Phase I/II: 100mg po d1,200mg po d2,400mg po d3-28.
Arm group label:
Venetoclax-Mitoxantrone liposome
Other name:
Venclexta
Summary:
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.
Detailed description:
This study is an open-label, single-arm, phase I/II clinical study. Phase I is a
multi-center, dose-escalation study. Following the "3+3" principle, it plans to recruit
9-18 patients with clinically diagnosed relapsed or refractory AML who will be treated
with venetoclax and mitoxantrone liposome, in order to explore the MTD of mitoxantrone
liposome, and determine the RP2D. Mitoxantrone liposome began to explore the dose from 24
mg/m^2, and every 4 weeks (28 days) was a cycle. Three dose groups of 24, 30 and 36
mg/m^2 were preseted; The trial phase includes screening period (within 28 days),
treatment period (planned 2 cycles), follow-up period (RFS and OS follow-up, planned 1
year).
Phase II is a multi-center, exploratory study, aiming to explore efficacy of venetoclax
combined with mitoxantrone liposome in the treatment of relapsed or refractory AML
patients, and to explore the differences in the efficacy of this combination therapy with
different gene mutations. After Phase I reaches MTD and the dose of Phase II is
determined, Phase II clinical trials will be carried out. The phase II trial phase
includes screening period (within 28 days) , treatment period (planned 6 cycles ) and a
follow-up period (RFS and OS follow-up, planned for 1 year).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. AML confirmed by bone marrow cytology and pathology;
2. Meet the diagnostic criteria for relapsed and refractory AML. Diagnostic criteria
for relapsed AML: leukemia cells reappeared in peripheral blood after complete
remission or blast cells in bone marrow >0.05 (except for other reasons such as bone
marrow regeneration after consolidation chemotherapy) or extramedullary leukemia
cell infiltration. Diagnostic criteria for refractory AML: naive patients who were
ineffective after 2 courses of standard regimens; patients who relapsed within 12
months after consolidation and intensive therapy after CR; patients who relapsed
after 12 months but were ineffective after conventional chemotherapy; 2 or more
Secondary relapse; persistent extramedullary leukemia;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
4. Liver and kidney function: Alanine aminotransferase (AST) and aspartate
aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (≤5 x ULN for patients
with liver infiltrates); Total bilirubin ≤1.5 x ULN (≤3 x ULN for patients with
liver infiltration); Serum creatinine ≤1.5 x ULN;
5. Normal cardiac function: left ventricular ejection fraction (LVEF) ≥ 45% assessed by
echocardiography or radionuclide active angiography (MUGA);
6. Pulmonary function: dyspnea ≤ CTC AE grade 1 and SaO2 ≥ 92% in indoor air
environment;
7. The expected survival time is greater than 3 months;
8. Patients voluntarily participated in this study and signed the informed consent.
Exclusion Criteria:
1. The subject had previously received any of the following anti-tumor treatments:
a)Those who have previously received mitoxantrone or mitoxantrone liposome;
b)Previously received doxorubicin or other anthracycline treatment, and the total
cumulative dose of doxorubicin is more than 360 mg/m^2 (1 mg doxorubicin converted
from other anthracycline drugs is equivalent to 2 mg daunorubicin or 0.5 mg
idarubicin); c)Have received anti-tumor treatment (including chemotherapy, targeted
therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor
activity, etc.) or participated in other clinical trials and received clinical trial
drugs within 4 weeks before the first use of the study drugs;
2. Heart function and disease meet one of the following conditions: a)Long QTc syndrome
or QTc interval > 480 ms; b)Complete left bundle branch block, grade II or III
atrioventricular block; c)Serious and uncontrolled arrhythmias requiring drug
treatment; d)New York Heart Association grade ≥ II; e)A history of myocardial
infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any
other arrhythmia requiring treatment, a history of clinically serious pericardial
disease, or ECG evidence of acute ischemia or active conduction system abnormalities
within 6 months before recruitment.
3. Identify patients with central nervous system invasion;
4. Other malignancies, except for effectively controlled non melanoma skin basal cell
carcinoma, breast / cervical carcinoma in situ, and other malignancies that have
been effectively controlled without treatment in the past five years;
5. Non controlled systemic diseases (such as active infection, non controlled
hypertension, diabetes, etc.);
6. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
7. Active hepatitis B and C infection (hepatitis B test: if there is a positive
hepatitis B surface antigen or core antibody, add HBV DNA, and the hepatitis B virus
DNA exceeds 1x10^3 copies/mL to exclude; hepatitis C: if the hepatitis C antibody is
positive, further test HCV RNA, hepatitis C Viral RNA exceeding 1x10^3 copies/mL was
excluded);
8. Hypersensitivity to any study drug or its components;
9. Pregnant women, lactating women, patients who refused to take effective
contraceptive measures during the study;
10. Serious neurological or psychiatric history;
11. Unsuitable subjects for this study determined by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Zip:
510632
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Zeng, MD
Start date:
July 21, 2022
Completion date:
May 2026
Lead sponsor:
Agency:
Hui Zeng
Agency class:
Other
Collaborator:
Agency:
CSPC Ouyi Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
First Affiliated Hospital of Jinan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522192