Clinical trial · Interventional
Plerixafor Plus Donor Lymphocyte Infusion for Relapsed Acute Leukemia After Allo-HSCT
A Single Arm Study of Using Plerixafor Plus Donor Lymphocyte Infusion in the Treatment of Patients With Relapsed Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed Adult ALL | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Adult AML | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Plerixafor plus DLI
- description
- DLI will be given to the participants three days after chemotherapy, and plerixafor will be administrated ten days post DLI.
- interventionNames
- Drug: Plerixafor
Primary outcomes (1)
- measure
- Remission rates of the enrolled participants
- timeFrame
- Three months
- description
- The remission rates of the participants include complete remission rate, partial remission rate, and overall response rate.
Secondary outcomes (5)
- measure
- Disease-free survival (DFS) of the enrolled participants
- timeFrame
- Twelve months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available