Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

NCT06621199 | Recruiting Phase 2

• 1 other identifier: CSPC-DED-AML-K15
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 2-year event-free survival (EFS) rate

  Defined for all patients in the study. Measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first.

  up to 2 years

Secondary Outcomes (6)

• Composite complete remission (CRc) rate of induction therapy

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

• Overall response rate (ORR) of induction therapy

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

• Relapsed-free survival (RFS)

  up to 2 years

• Overall survival (OS)

  up to 2 years

• Rate of CR/CRi without measurable residual disease after induction therapy

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

Study Arms (1)

Modified MAV regimen

EXPERIMENTAL

Mitoxantrone hydrochloride liposome ×1 day, cytarabine × 5 days combined with venetoclax as induction regimen

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

Modified MAV regimen

Cytarabine DRUG

Cytarabine 100 mg/m\^2 on day 1-5, every 4 weeks

Modified MAV regimen

Venetoclax DRUG

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

Modified MAV regimen

Eligibility Criteria

• Age: 60 Years - 70 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.
• Aged 60-70 years (including boundary values 60 and 70);
• Newly diagnosed primary AML according to the WHO 2022 classification.
• Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
• Life expectancy ≥ 3 months.
• ALT/AST≤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:

• Subjects meet any of the following conditions:
• Acute promyelocytic leukemia;
• Secondary AML caused by chemotherapy and/or radiotherapy to treat solid tumor or antecedent hematological disorders such as MDS, MPN, MDS/MPN;
• AML following blast transformation of prior chronic myeloid leukemia;
• Central nervous system (CNS) leukemia;
• Subjects with malignant tumors (excluding cured skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past 5 years) within the past 5 years.
• Subjects who have received anthracycline pretreatment or other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments);
• Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
• Subjects who are unable to take oral medications or have malabsorption syndrome;
• Cardiac function and disease conform to one of the following conditions:
• Long QTc syndrome or QTc interval \>480 ms;
• Complete left bundle branch block, degree II or III atrioventricular block;
• Severe, uncontrolled arrhythmia requiring medical treatment;
• New York Heart Association(NYHA) classification ≥ grade II;
• Cardiac ejection fraction (EF) was less than 50%;

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

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: September 29, 2024
• First Posted: October 1, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-07

Locations

CN (1)