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;
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.
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;
Single group
Mitoxantrone hydrochloride liposome
DrugVeneclatra (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.
CRR
All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks
PR
The maximum sum of diameters of tumor lesions decrease≥ 30% and is maintained for at least 4 weeks
ORR
CR+PR
2-year OS
The time from the start of treatment to death due to any reason
DFS
The time from the start of treatment to disease recurrence or death from any cause
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