Phase
Condition
Lymphocytic Leukemia, Acute
Leukemia
Treatment
blinatumomab and auto-HSCT "sandwich " strategy
Clinical Study ID
Ages 15-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
subjects with a primary diagnosis of B-ALL who have any of the following: (a) nosuitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.
positive expression of CD19 in peripheral blood or bone marrow primary cellsdetected by flow cytometry.
ardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl;alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normalrange and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAEv5.0) with oxygen saturation > 91% without oxygenation.
subjects aged 15-65 years (including 15 and 65 years), regardless of gender.
T-cell amplification test pass.
expected survival > 3 months.
Exclusion
Exclusion Criteria:
patients with recurrence of only isolated extramedullary lesions. combination ofother malignant tumors.
previously treated with anti-CD19 therapies.
immunosuppressants use within 2 weeks prior to signing informed consent or plan toimmunosuppressants after signing informed consent.
uncontrolled active infections.
HIV infection.
active hepatitis B or hepatitis C infection.
history of severe tachyphylaxis to aminoglycoside antibiotics.
history or presence of clinically relevant Central Nervous System (CNS) pathology,such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severebrain injuries, dementia, Parkinson's disease, cerebellar disease, organic brainsyndrome, or psychosis.
Study Design
Study Description
Connect with a study center
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
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