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Trial Title:
Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML
NCT ID:
NCT06434662
Condition:
Relapsed/Refractory Acute Myeloid Leukaemia
Myeloid Malignancy
Conditions: Official terms:
Cytarabine
Venetoclax
Mitoxantrone
Study type:
Interventional
Study phase:
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 hydrochloride liposome
Description:
Mitoxantrone hydrochloride liposome (24 mg/m^2) on day 1, every 4 weeks
Arm group label:
MAV regimen
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Cytarabine (1.0 g/m^2, q12h ) on day 1,3,5, every 4 weeks
Arm group label:
MAV regimen
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks
Arm group label:
MAV regimen
Summary:
The goal of this study is to evaluate the efficacy and safety of a combination regimen of
mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the
treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the
correlation between different biological characteristics and therapeutic efficacy. The
main questions it aims to answer are:Dose the combination regimen of MAV enhanced the
composite complete remission in R/R AML? Participants will receive laboratory tests of
bone marrow and blood specimens at regular times after MAV treatment.
Detailed description:
Acute myeloid leukemia (AML) is a highly aggressive hematologic malignancy with a poor
prognosis. The "3+7" regimen, combining anthracyclines with cytarabine, remains the
standard treatment for first line treatment. However, about 20% of patients will develop
into primary refractory disease, and more than 50% of patients who achieved complete
remission will eventually relapse. For patients with R/R AML, there is currently no
established standard treatment. Combining the third drugs with "3+7" regimen is one of
the clinical exploration directions.
The purpose of this prospective, single-center, single-arm, pahse II study is to evaluate
the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome
injection, cytarabine and venetoclax in the treatment of R/R AML. All participants will
receive MAV treatment including 24 mg/m2 mitoxantrone hydrochloride liposome on day 1,
1.0 g/m2 q12h cytarabine on day 1,3,5 and 400 mg venetoclax on day 2-10 with a dose
escalation on day 2-4. Each cycle consists of 4 weeks. A maximum of 2 cycles of therapy
are planned.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Each subject must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study.
2. Age ≥18.
3. Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic
leukemia.
1. Initial treatment patients who failed after 2 courses of treatment with
standard regimen.
2. Bone marrow blasts≥5% after the first CR/CRi, or reappearance of blasts in the
blood in at least 2 peripheral blood samples at least one week apart, or
leukemia cell infiltration appeared in extramedullary without treatment.
3. First conversion from MRD negativity to MRD positivity without treatment.
4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
5. Researchers determined that the patients could tolerate intensive chemotherapy.
6. Life expectancy > 3 months.
7. AST/ALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5
ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.
Exclusion Criteria:
1. Previous anti-tumor therapy meets one of the following criteria:
1. Prior therapy with mitoxantrone or mitoxantrone liposome;
2. Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of
doxorubicin > 360 mg/m^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin
or 0.5 mg idarubicin);
3. Have received other anti-tumor therapy (including chemotherapy, targeted
therapy, hormone therapy, Chinese medicines with anti-tumor activity, except
those that do not affect the efficacy of the study as determined by the
investigator) or participated in other clinical trials and received clinical
trial drugs within 4 weeks or 5 half-lives of the drug before the study;
2. Cardiovascular diseases, including but not limited to:
1. QTc interval >480 ms or long QTc syndrome in screening;
2. Complete left bundle branch block, 2 or 3 grade atrioventricular block;
3. Requiring treatment of serious and uncontrolled arrhythmia;
4. New York Heart Association（NYHA≥3;
5. Cardiac ejection fraction (EF) was less than 50%;
6. Myocardial infarction, unstable angina pectoris, severe unstable ventricular
arrhythmia or any other history of arrhythmia or clinically serious pericardial
disease that requires treatment within the first 6 months of enrollment, or
electrocardiographic evidence of acute ischemic or active conduction system
abnormalities.
3. Central nervous system leukemia;
4. Previous or current occurrence of other malignancies (in addition to non-melanoma
basal cell carcinoma of the skin that is effectively controlled, breast/cervical
carcinoma in situ, and other malignancies that have been effectively controlled
without treatment within the past five years).
5. Subjects are suffering from any other uncontrollable disease (including but not
limited to: uncontrolled diabetes and hypertension, and advanced infection);
6. HIV infection.
7. HBsAg or HBcAb positive, with HBV-DNA≥1x10^3 copies/mL; or HCV-RNA≥1x10^3 copies/mL;
8. A history of immediate or delayed allergy to similar drug and excipients of the
investigate drug.
9. Pregnant, lactating female or subjects who refuse to use effective contraception
during the study.
10. With a history of severe neurological or psychiatric illness.
11. Not suitable for this study as decided by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin, M.D.
Phone:
+86 571-87236896
Email:
jiej0503@163.com
Start date:
February 29, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Collaborator:
Agency:
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Agency class:
Industry
Source:
First Affiliated Hospital of Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434662
