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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with B-ALL receiving allogeneic hematopoietic stem cell transplantation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CIR) | Cumulative recurrence rate (CIR) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | 2 Overall survival (OS) | 2 years |
| RFS | relapse-free survival (RFS) | 2 years |
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Inclusion Criteria:
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.](streamdown:incomplete-link)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| donglin yang | Contact | 13902087176 | yangdonglin@ihcams.ac.cn |
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| incidence of acute and chronic GVHD | incidence of acute and chronic GVHD | 1-year |
| ID | Term |
|---|---|
| C510808 | blinatumomab |
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