A multicenter non-blinded non-controlled trial to assess the safty and efficacy of post-hematopoietic cell transplanation maintenance therapy by blinatumomab for relapsed/refractory CD19 positive B-cell acute lymphoblastic leukemia: a phase 1-2 study - JPLSG-SCT-ALL-BLIN21

Sakaguchi Hirotoshi0 个研究点目标入组 41 人开始时间: 2022年3月3日最近更新: 2023年10月17日

研究概览

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•1) Patients with CD19 positive precursor B-Cell Acute Lymphoblastic Leukemia, younger than 25 years old at the time of enrollment
•2) ECOG-PS 2 or less
•3) Clinica stage at the time of receiving allogeneic hematopoietic stem cell transplantation;
•Clinical stage beyond the first complete remission.
•4) At the time of enrollment, patients must have achieved a neutrophil count of 0.5x10^9/L or higher without 48 hours of G-CSF administration and a platelet count of 20,000 or higher without 72 hours of platelet transfusion at least 30 days but less than 100 days after transplantation.
•5) Hematological remission is confirmed by bone marrow test performed at the time of enrollment
•6) Written informed consent obtained from patient or guardians.

•1) If antileukemic agents other than blinatumomab is administered after transplantation for the purpose of treating the primary disease
•2) Active grade 2-4 acute GvHD or moderate to severe chronic GvHD at the time of enrollment, and immunosuppressive drugs (including systemic steroids) are being administered for the treatment of GvHD. Administration of immunosuppressive agents for the prevention of GvHD is acceptable. Topical steroids for acute grade 1 GvHD (skin manifestations up to stage 2) are acceptable.
•3) If central nervous system lesions are present at the time of enrollment
•4) Less than 20% of CD19 expression rate of blasts assessed at the diagnosis or relapse
•5) Four or more consecutive courses of blinatumomab up to just before the start of the pre-transplant conditining regimen
•6) Have enrolled in this study after a previous transplantation
•7) Have an active infection at the time of enrollment
•8) At the time of enrollment, patients have any of the following: hepatic impairment (AST/ALT >5xULN, T-Bil >2.5xULN), renal impairment (Cre >2xULN), respiratory impairment requiring oxygenation, heart failure with EF <40%, or neurological disease with frequent seizures
•9) HIV antibody positive, HBs antigen positive or HCV antibody positive
•10) Women who are pregnant or may become pregnant
•11) If the principal investigator or sub-investigator judges that participation in this study is not appropriate.

发起方

Sakaguchi Hirotoshi