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Trial Title:
Plerixafor Plus Donor Lymphocyte Infusion for Relapsed Acute Leukemia After Allo-HSCT
NCT ID:
NCT06141304
Condition:
Relapsed Adult ALL
Relapsed Adult AML
Conditions: Official terms:
Leukemia
Plerixafor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Plerixafor plus donor lymphocyte infusion for patients with relapsed acute leukemia
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Plerixafor
Description:
Plerixafor was injected subcutaneously to participants twice per day for five consecutive
days ten days post DLI.
Arm group label:
Plerixafor plus DLI
Other name:
AMD3100
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.
Criteria for 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.
Gender:
All
Minimum age:
14 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Start date:
September 1, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06141304
