Acute Lymphoblastic Leukemia
Conditions
Interventions
Recipient Group:Administer recipient-derived CD19 CAR-T cell therapy
Donor Group:Administer donor-derived CD19 CAR-T cell therapy
Sponsors
Medical Center of Hematology, Xinqiao Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Between January 2018 and February 2024, patients aged 18-65 years with B-ALL who relapsed after allogeneic hematopoietic stem cell transplantation were selected from New Bridge Hospital affiliated with Army Medical University, Zhujiang Hospital affiliated with Southern Medical University, Henan Cancer Hospital, Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, Shaanxi Provincial People's Hospital, General Hospital of Western Theater Command, and First Affiliated Hospital of Zhejiang University Medical College. Allogeneic haematopoietic stem cells were defined as transplants from sibling or unrelated donors. Post-transplant relapse was defined as ? more than 5% primitive lymphocytes in the bone marrow; ? positive minimal residual disease (MRD): blasts =5% in the bone marrow, with primitive lymphocytes detectable by multicolour FCM (>0. 01%) or specific genes (such as BCR-ABL fusion genes) by real-time quantitative PCR (qPCR); ? positive extramedullary relapse (EMR): Confirmed independent extramedullary relapse by single-site biopsy or multiple extramedullary relapses confirmed by PET-CT; patients were excluded if they refused chemotherapy, second allogeneic bone marrow transplant or DLI; ? Positive CD19 expression on tumour cells in bone marrow or peripheral blood; ? Received CAR-T cell therapy from donor or autologous sources after relapse, with donor sources defined as coming from the same individual as the allogeneic haematopoietic stem cell transplant; ? An ECOG (Eastern Cooperative Oncology Group performance score) of =2; ? An expected survival of more than 3 months.
Exclusion criteria
Exclusion criteria: ? Have received other CD19-targeted drugs; ? Have had acute GVHD of grades II-IV (Glucksberg criteria) or extensive chronic GVHD in the past; ? Have other malignancies; ? Pregnant or lactating women; ? Have clinical symptoms of brain dysfunction or severe mental disorders that prevent understanding or compliance with the study protocol; ? Poor compliance due to physiological, family, social, geographical, or psychological factors, making it difficult to cooperate with the study protocol and follow-up plans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Event-Free Survival; | — |
Countries
China
Contacts
Public ContactXi Zhang
Medical Center of Hematology, Xinqiao Hospital of Army Medical University
Outcome results
None listed