Clinical trial NCT06447090: VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT
Official title: Study on the Efficacy and Safety of VMAC Combined With Donor Lymphocyte Infusion (DLI) in the Treatment of Patients With Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Relapse Acute Myeloid Leukemia
Keywords: Mitoxantrone liposome
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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;

Detailed description: venetoclax 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; liposomal mitoxantrone 30 mg/m2/d, d1; cytarabine (Ara-C) 100 mg/m2/d, d1-7; cyclophosphamide (CY) 400 mg/m2/d, d2, 5)，and then rest for 1 day before giving cryopreserved donor stem cells.MNC1-2X10\^8/kg infusion, low-dose (25 mg Bid), short-course treatment (2-3 weeks after DLI) oral cyclosporine (CSA) is added to prevent graft-versus-host disease starting 3 days before the infusion of cryopreserved stem cells.

Monitor the occurrence of serious infections, cardiac toxicity, GVHD and other adverse reactions during the medication process; Blood routine recovery or bone marrow re examination 4 weeks after DLI to evaluate the efficacy of one course of VMAC combined with DLI; The patient was followed up for 2 years to evaluate long-term efficacy.

Eligibility criteria: Inclusion Criteria:

1. Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
2. Age ≥18 years and ≤65 years old, regardless of gender;
3. Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
4. 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.

Exclusion Criteria:

Subjects who meet any of the following criteria shall not be enrolled in this study:

* 1) Secondary transplant patients;
* 2) 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);
* 3) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
* 4) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
* 5) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
* 6) Active heart disease, definition One or more of the following:

  1. Long QTc syndrome or QTc interval \>480ms;
  2. Complete left bundle branch block, II or III degree atrioventricular block;
  3. Need for drug treatment or History of severe arrhythmia with clinical symptoms;
  4. New York Heart Association classification ≥ II;
  5. Left ventricular ejection fraction less than 50%;
  6. 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.
* 7) Transplantation from an unrelated donor;
* 8) Those deemed not suitable for enrollment by the researcher.

Primary outcomes:
measure: CRR
timeFrame: 1 year
Secondary outcomes:
measure: PR
timeFrame: 1 year
measure: ORR
timeFrame: 1year
measure: 2-year OS
timeFrame: 2 years
measure: DFS
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, China
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Xin Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: