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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06141304
Other study ID # MLEU
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2023
Est. completion date July 2025

Study information

Verified date November 2023
Source The First Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute leukemia, including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), is the subtype of leukemia with the highest mortality, and leukemia relapse caused by the protective bone marrow microenvironment is the main cause of treatment failure. The chemokine receptor CXCR4 plays a crucial role in the homing and settling of leukemia cells into the bone marrow. Preclinical study of the investigators demonstrates that CXCR4 blockade can mobilize leukemia cells from their protective bone marrow microenvironment to periphery, thereby significantly enhancing the killing effect of allogeneic lymphocytes against leukemia cells. This study aims to preliminarily evaluate the efficacy and safety of donor lymphocyte infusion (DLI) plus CXCR4 antagonist plerixafor in the treatment of relapsed acute leukemia patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) through a prospective single arm study. The results may preliminarily confirm the effectiveness and safety of DLI combined with plerixafor in the treatment of recurrent acute leukemia patients after allo-HSCT, providing a reference basis for further research.


Description:

Patients with relapsed acute leukemia post allo-HSCT will be screened for the eligibility of this clinical trial. The participants will receive chemotherapy to reduce leukemia burden followed by DLI three days later. Ten days post DLI, plerixafor will be administrated to the participants (subcutaneous injection, twice per day) for a consecutive five days. The second round of DLI plus plerixafor will be given if the participants achieving partial remission or complete remission with positive minimal measurable disease. Short-term responses and long-term outcomes will be evaluated and safety of this therapeutic regimen will be assessed.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Plerixafor
Plerixafor was injected subcutaneously to participants twice per day for five consecutive days ten days post DLI.

Locations

Country Name City State
China First Hospital of Jilin University Changchun Jilin

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Remission rates of the enrolled participants The remission rates of the participants include complete remission rate, partial remission rate, and overall response rate. Three months
Secondary Disease-free survival (DFS) of the enrolled participants DFS is defined from achievement of complete remission to disease relapse. Twelve months
Secondary Overall survival of the enrolled participants DFS is defined from enrollment to death, last contact, or end of this clinical trial. Twelve months
Secondary Number of participants with acute and chronic graft-versus-host disease (GVHD) Any grade of acute and chronic GVHD of the participants will be recorded. The acute GVHD will be assessed by MAGIC guidelines and chronic GVHD will be assessed by National Comprehensive Cancer Network (NCCN) guidelines. Twelve months
Secondary Number of participants with non-relapse mortality Non-relapse mortality (NRM) is defined as any cause of death without leukemia relapse. Twelve months
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Treatment-related adverse events will be assessed by CTCAE v5.0, including hematological and non-hematological adverse events. However, the occurrence of GVHD is not included. One month after treatment
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