Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML

NCT06434662 | Recruiting Phase 2 DMC

• 1 other identifier: CSPC-DED-AML-K13
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory Acute Myeloid Leukaemia; Myeloid Malignancy

Outcome Measures

Primary Outcomes (1)

• Composite complete remission (CRc) rate

  Blast rate lower than 5% with or without peripheral blood cell recover

  At the end of each cycle (each cycle is 28 days), up to 2 cycles

Secondary Outcomes (6)

• Overall response rate (ORR)

  At the end of each cycle (each cycle is 28 days), up to 2 cycles

• Relapsed free survival (RFS)

  up to 12 months

• Event free survival (EFS)

  up to 12 months

• overall survival (OS)

  up to 12 months

• Rate of CR without minimal residual disease (CR MRD-)

  At the end of each cycle (each cycle is 28 days), up to 2 cycles

Study Arms (1)

MAV regimen

EXPERIMENTAL

mitoxantrone hydrochloride liposome injection, cytarabine combined with venetoclax

Drug: mitoxantrone hydrochloride liposome; Drug: Cytarabine; Drug: Venetoclax

Interventions

mitoxantrone hydrochloride liposome DRUG

Mitoxantrone hydrochloride liposome (24 mg/m\^2) on day 1, every 4 weeks

MAV regimen

Cytarabine DRUG

Cytarabine (1.0 g/m\^2, q12h ) on day 1,3,5, every 4 weeks

MAV regimen

Venetoclax DRUG

Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks

MAV regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥18.
• Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
• Initial treatment patients who failed after 2 courses of treatment with standard regimen.
• 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.
• First conversion from MRD negativity to MRD positivity without treatment.
• Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
• Researchers determined that the patients could tolerate intensive chemotherapy.
• Life expectancy \> 3 months.
• 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.

You may not qualify if:

• Previous anti-tumor therapy meets one of the following criteria:
• Prior therapy with mitoxantrone or mitoxantrone liposome;
• 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);
• 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;
• Cardiovascular diseases, including but not limited to:
• QTc interval \>480 ms or long QTc syndrome in screening;
• Complete left bundle branch block, 2 or 3 grade atrioventricular block;
• Requiring treatment of serious and uncontrolled arrhythmia;
• New York Heart Association（NYHA≥3;
• Cardiac ejection fraction (EF) was less than 50%;
• 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.
• Central nervous system leukemia;
• 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).
• Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);
• HIV infection.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jie Jin, M.D.

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jin, M.D.

CONTACT

+86 571-87236896; jiej0503@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 30, 2024
• Study Start: February 29, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)