Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, 300000, China
Location status: Recruiting
NCT Number: NCT06447090
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;
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300000, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects who meet any of the following criteria shall not be enrolled in this study:
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.
Other names: Venetoclax, Cytarabine,Cytosine arabinoside, Cyclophosphamide
Time frame: 1 year
All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks
Time frame: 1 year
The maximum sum of diameters of tumor lesions decrease≥ 30% and is maintained for at least 4 weeks
Time frame: 1year
CR+PR
Time frame: 2 years
The time from the start of treatment to death due to any reason
Time frame: 2 years
The time from the start of treatment to disease recurrence or death from any cause
Contact information is provided by the study sponsor or research team.
Xin Chen, Doctor
CONTACT
Xueou Liu, Doctor
CONTACT
Institute of Hematology & Blood Diseases Hospital, China
Other
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
Acronym: VMAC+DLI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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Acute Myeloid Leukemia (AML), Hematologic Diseases
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View Trial Details