Status:
UNKNOWN
Plerixafor Plus Donor Lymphocyte Infusion for Relapsed Acute Leukemia After Allo-HSCT
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Relapsed Adult ALL
Relapsed Adult AML
Eligibility:
All Genders
14-60 years
Phase:
PHASE2
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06141304
Start Date
September 1 2023
End Date
July 1 2025
Last Update
November 21 2023
Active Locations (1)
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1
First Hospital of Jilin University
Changchun, Jilin, China, 130021