Status:
RECRUITING
Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
15-65 years
Phase:
PHASE1
Brief Summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main method potentially curing adult B-ALL, but the high treatment-related mortality (NRM) affects overall survival (OS). Autologo...
Detailed Description
Enrolled patients received induction chemotherapy with the IVP regimen and two cycles of consolidation chemotherapy: high-dose cytarabine (Ara-c) + pegaspargase (± Tyrosine kinase inhibitors ,TKI) and...
Eligibility Criteria
Inclusion
- subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.
- positive expression of CD19 in peripheral blood or bone marrow primary cells detected 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 normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) 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
- patients with recurrence of only isolated extramedullary lesions. combination of other malignant tumors.
- previously treated with anti-CD19 therapies.
- immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants 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, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06507514
Start Date
April 1 2024
End Date
April 1 2030
Last Update
November 21 2025
Active Locations (1)
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1
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006