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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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;

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital, China
RECRUITING
Tianjin
Contact Information
Primary
Xin Chen, Doctor
chenxin@ihcams.ac.cn
13920985705
Backup
Xueou Liu, Doctor
ec@ihcams.ac.cn
022-23909095
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 30
Treatments
Experimental: VMAC+DLI
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.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

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