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Plerixafor Plus Donor Lymphocyte Infusion for Relapsed Acute Leukemia After Allo-HSCT

NCT06141304 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-11-21

No results posted yet for this study

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.

Conditions

  • Relapsed Adult ALL
  • Relapsed Adult AML

Interventions

DRUG

Plerixafor

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

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Long Su, PhD · The First Hospital of Jilin University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-01-31
Completion
2025-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06141304 on ClinicalTrials.gov