Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447090
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-06-03
Brief Title:
VMACDLI Treatment of Patients With Relapse of AML After Allo-HSCT
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VMACDLI
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
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 mgd reduced to 100 mg when combined with an azole d1-7 liposomal mitoxantrone 30 mgm2d d1 cytarabine Ara-C 100 mgm2d d1-7 cyclophosphamide CY 400 mgm2d d2 5and then rest for 1 day before giving cryopreserved donor stem cellsMNC1-2X108kg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None