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

Phase 2

Active, not recruiting

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 ...

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. Th...

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Plerixafor plus DLI	Plerixafor	DLI will be given to the participants three days after chemotherapy, and plerixafor will be administrated ten days post DLI.

Primary Outcome Measures

Name	Time	Method
Remission rates of the enrolled participants	Three months	The remission rates of the participants include complete remission rate, partial remission rate, and overall response rate.

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS) of the enrolled participants	Twelve months	DFS is defined from achievement of complete remission to disease relapse.
Overall survival of the enrolled participants	Twelve months	DFS is defined from enrollment to death, last contact, or end of this clinical trial.
Number of participants with acute and chronic graft-versus-host disease (GVHD)	Twelve months	Any grade of acute and chronic GVHD of the participants will be recorded. The acute GVHD will be assessed by MAGIC guidelines and chronic GVHD will be assessed by National Comprehensive Cancer Network (NCCN) guidelines.
Number of participants with non-relapse mortality	Twelve months	Non-relapse mortality (NRM) is defined as any cause of death without leukemia relapse.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	One month after treatment	Treatment-related adverse events will be assessed by CTCAE v5.0, including hematological and non-hematological adverse events. However, the occurrence of GVHD is not included.

Locations (1): First Hospital of Jilin University
🇨🇳
Changchun, Jilin, China

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