Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL
B-cell Acute Lymphoblastic Leukemia
About this trial
This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
- ECOG score is 0-2.
- Expecting life span is more than 6 months.
- Patients are free from severe organ dysfunction.
Exclusion Criteria:
- Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) <30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) >2.5mg/ dL or blood Creatinine clearance rate < 30ml/min.
- Patients are combined with infection or other complications that can not tolerate chemotherapy.
- Patients are suffering from central nervous system/solitary extramedullary leukemia.
- Patients are considered as tumer progression.
- Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
- Pregnant and lactating women will not be included.
Sites / Locations
- The first affiliated hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Blinatumomab arm
Conventional therapy
On the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day.
Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.