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

NCT ID: NCT06141304

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-07-31

Brief 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.

Detailed 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.

Conditions

Relapsed Adult ALL; Relapsed Adult AML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plerixafor plus DLI

DLI will be given to the participants three days after chemotherapy, and plerixafor will be administrated ten days post DLI.

Group Type: EXPERIMENTAL

Plerixafor

Intervention Type: DRUG

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

Interventions

Plerixafor

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

Intervention Type: DRUG

Other Intervention Names

AMD3100

Eligibility Criteria

Inclusion Criteria

• The age of the patients is ≥ 14 and ≤ 60 years old;
• Those with relapsed acute leukemia after allo-HSCT with bone marrow blasts less than 50%;
• The expected survival exceeds 3 months;
• At least 100 days post transplantation, and the immunosuppressants were discontinued;
• Those with no significant abnormalities of the main organ function: creatinine ≤ 176.8 μ Mol/L, bilirubin ≤ 51.3 μ Mol/L, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the normal upper limit;
• Sign an informed consent form.

Exclusion Criteria

• Those with patient-specific human leukocyte antigen (HLA) loss at relapse;
• Those with active graft-versus-host disease;
• Those with severe infection;
• Those with organ function failure;
• Those with an Eastern Cooperative Oncology Group (ECOG) score more than 2 points;
• Those who are allergic to experimental drugs;
• Those who use other anti-leukemia therapies, such as radiotherapy, cellular immunotherapy, or Chinese medical herbs;
• Those participate in other clinical trials simultaneously;
• Those having mental illness or other illnesses that cannot fully comply with treatment or follow-up requirements;
• Those with extramedullary leukemia;
• Those with other conditions that researchers evaluate who are not proper to participate in this clinical trial.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

SuJun Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Long Su, PhD

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

MLEU

Identifier Type: -

Identifier Source: org_study_id