B-cell precursor acute lymphoblastic leukemia children/adolescent and young adult, relapsed/refractory, Precursor B-Cell Acute Lymphoblastic Leukemia
Conditions
Interventions
The patients who underwent allogeneic hematopoietic stem cell transplantation for B-cell acute lymphoblastic leukemia in non-remission or third complete remission (phase 1), or in disease stage beyond
C510808
blinatumomab, maintenance therapy after allogeneic hematopoietic stem cell transplantation
Sponsors
Koh Katsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Study treatment completion rate Phase II GvHD-free, relapse-free survival rate at 1 year after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I Percentage of NCI-CTCAE ver5.0 grade 3 or higher adverse events within each course Phase II Incidence of GvHD at 1 year after transplantation Incidence of secondary graft failure at 1 year after transplantation Incidence of relapse at 1 year after transplantation Non-relapse mortality rate at 1 year after transplantation Disease-free survival rate at 1 year after transplantation Overall survival rate at 1 year after transplantation Percentage of NCI-CTCAE ver5.0 grade 3 or higher adverse events within each course | — |
Contacts
Public ContactHirotoshi Sakaguchi
National Center for Child Health and Development
Outcome results
None listed