A Phase 2 interventional study of Azacitidine Injection and Venetoclax in B Acute Lymphoblastic Leukemia, Ph-Negative ALL and High Risk Acute Lymphoblastic Leukemia, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment
Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
Therapeutic outcomes in adults with Ph- B-ALL have substantially improved in the last decade, with complete remission (CR) and long-term overall survival (OS) rates of around 90% and 40%-50%, respectively. The presence of measurable residual disease (MRD) is the strongest predictor of relapse in B-ALL. In this study, high risk Ph- B-ALL patients receive the induction chemotherapy with Azacitidine+Venetoclax. After induction chemotherapy with Azacitidine+Venetoclax (VA regime), each subject receives CD19CD22 CAR-T cells by intravenous infusion. The patients with MRD negative will undergo HSCT.
Drug: Azacitidine Injection · Drug: Venetoclax · Drug: CD19CD22 CAR-T
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
Also known as: Azacitidine
Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
Also known as: ABT-199
After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion
Also known as: GDC-0199
Complete Remission Rate
MRD Negative Remission Rate after CD19CD22 cell therapy
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Complete Remission Rate of VA regime
Complete Remission Rate after VA regime
Time frame: The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime
Complete Molecular Remission Rate
Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Overall survival (OS)
From the first infusion of CD19CD22 cells to death or the last visit
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Leukemia-free survival (LFS)
Up to 2 years after CD19CD22 CAR-T cells infusion
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Plan to share: No
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The First Affiliated Hospital of Soochow University