blinatumomab as maintenance therapy in patients with high-risk b-lineage acute lymphoblastic leukemia post allogeneic hematopoietic cell transplantation

Conditions: B-ALL

Summary: 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.

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. beginning 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

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.). 3.markedly abnormal screening laboratory tests: a) alanine aminotransferase (alt) ≥ 5 × uln (upper limit of normal); b) aspartate aminotransferase (ast) ≥ 5 × uln; c) total bilirubin (tbil) ≥ 3 × uln; d) creatinine clearance \< 70 ml/min at screening; patients with active hepatitis b (hepatitis b surface antigen positive and peripheral blood hepatitis b virus deoxyribonucleic acid (hbv dna) ≥ 1 × 102 copies/ml); f) hepatitis c antibody positive; g) human immunodeficiency virus (hiv) positive; h) treponema pallidum antibody positive; 4.ecog performance status ≥ 3 5.estimated survival less than 3 months this study may not be completed for other reasons, or the investigator considers it inappropriate to participate in this study.

Keywords: allogeneic hematopoietic stem cell transplantation