VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT

NCT06447090 | Recruiting Phase 2

• 1 other identifier: IIT2024002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation. The main questions it aims to answer are: The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;

Conditions

Relapse Acute Myeloid Leukemia

Keywords

Mitoxantrone liposome

Outcome Measures

Primary Outcomes (1)

• CRR

  All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks

  1 year

Secondary Outcomes (4)

• PR

  1 year

• ORR

  1year

• 2-year OS

  2 years

• DFS

  2 years

Study Arms (1)

VMAC+DLI

EXPERIMENTAL

VMAC regimen : Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10\^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.

Drug: Mitoxantrone hydrochloride liposome

Interventions

Mitoxantrone hydrochloride liposome DRUG

Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10\^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.

Also known as: Venetoclax, Cytarabine,Cytosine arabinoside, Cyclophosphamide

VMAC+DLI

Eligibility Criteria

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

You may qualify if:

• Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
• Age ≥18 years and ≤65 years old, regardless of gender;
• Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
• An informed consent form must be signed before the start of the research procedure, and the patient himself or his immediate family members must sign the informed consent form. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member will sign the informed consent form.

You may not qualify if:

• Subjects who meet any of the following criteria shall not be enrolled in this study:
• \) Secondary transplant patients;
• \) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer , basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN);
• \) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
• \) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
• \) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
• \) Active heart disease, definition One or more of the following:
• Long QTc syndrome or QTc interval \>480ms;
• Complete left bundle branch block, II or III degree atrioventricular block;
• Need for drug treatment or History of severe arrhythmia with clinical symptoms;
• New York Heart Association classification ≥ II;
• Left ventricular ejection fraction less than 50%;
• Myocardial infarction, unstable angina, severe myocardial infarction within 6 months before enrollment History of unstable ventricular arrhythmias or any other arrhythmias requiring treatment, clinically severe pericardial disease, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• \) Transplantation from an unrelated donor;
• \) Those deemed not suitable for enrollment by the researcher.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Interventions

venetoclax; Cytarabine; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Xin Chen, Doctor

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Chen, Doctor

CONTACT

13920985705; chenxin@ihcams.ac.cn

Xueou Liu, Doctor

CONTACT

022-23909095; ec@ihcams.ac.cn

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: June 3, 2024
• First Posted: June 6, 2024
• Study Start: April 12, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 6, 2024

Record last verified: 2024-05

Locations

CN (1)