About this trial
Patients ≥ 14 years of age after B-ALL allogeneic transplantation received 4 cycles of maintenance therapy with blinatumomab +/- TKI and were followed for more than 1 year to assess overall survival (OS), relapse-free survival (RFS), incidence of acute and chronic GVHD, safety, etc.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1.Age ≥ 14 years, male or female; 2.CD19 + acute B lymphoblastic leukemia treated with allogeneic hematopoietic stem cell transplantation [Patients, the types of transplantation include fully matched sibling transplantation, haploidentical related donor transplantation and unrelated donor transplantation; 3.CD19 + acute B-lymphoblastic leukemia at risk of relapse before transplantation [including but not limited to: refractory leukemia: failure to achieve complete remission (CR)/CR with partial hematological recovery (CRh)/CR with incomplete hematological recovery (CRi) or CR/CRh/CRi after the end of induction therapy (generally refers to 4-week regimen or Hyper-CVAD regimen), but still positive for measurable residual disease (MRD); relapsed leukemia: patients who have achieved CR have blasts in peripheral blood or bone marrow (proportion > 5%), or extramedullary disease; onset of white blood cells > 30 × 109/L; patients with poor prognosis cytogenetic abnormalities; patients with positive residual leukemia before transplantation, etc.] 4.The disease is in complete remission, and residual leukemia is negative, absolute neutrophil count ≥ 1.0 × 109/L, platelet count ≥ 50 × 109/L, lasting for more than a week; 5.Freedom from ≥ Grade 3 acute GVHD or uncontrolled moderate to severe chronic GVHD within 30 days prior to enrollment; Awareness and willingness to sign written informed consent.
Disqualifiers
1.Patients with hematological relapse or minimal residual disease relapse of B-ALL after transplantation; 2.Presence of serious uncontrolled active infection (e.g., sepsis, pulmonary infection, etc.).
Trial design
Single group
Treatments tested in this trial
Blinatumomab
DrugBeginning 3 months after transplantation, 1 cycle of blinatumomab was performed every 3 months for a total of 4 maintenance cycles. Dosage of blinatumomab: 9 ug/d D1-4, 28 ug/d D5-14
Treatment groups
Trial outcomes
Primary outcomes
CIR)
Cumulative recurrence rate (CIR)
Secondary outcomes
OS
2 Overall survival (OS)
RFS
relapse-free survival (RFS)
incidence of acute and chronic GVHD
incidence of acute and chronic GVHD
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: