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

NCT06141304 | Unknown Phase 2 DMC

• 1 other identifier: MLEU
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed Adult ALL; Relapsed Adult AML

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disease-free survival (DFS) of the enrolled participants

  Twelve months

• Overall survival of the enrolled participants

  Twelve months

• Number of participants with acute and chronic graft-versus-host disease (GVHD)

  Twelve months

• Number of participants with non-relapse mortality

  Twelve months

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  One month after treatment

Study Arms (1)

Plerixafor plus DLI

EXPERIMENTAL

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

Drug: Plerixafor

Interventions

Plerixafor DRUG

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

Also known as: AMD3100

Plerixafor plus DLI

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Officials

• Long Su, PhD

  The First Hospital of Jilin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Plerixafor plus donor lymphocyte infusion for patients with relapsed acute leukemia

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

CN (1)