Leukemia Clinical Trial
Official title:
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia
Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial PDT-ALL-LBL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated from induction therapy to maintenance therapy, along with higher dose of consolidation regimen of cytarabine, methotrexate, cyclophosphamide.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | May 30, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 14-55 years old; - LBL/ALL newly diagnosed; - signed written informed consent. Exclusion Criteria: - Pregnant women; - History of pancreatitis; - History of diabetes; - History of active peptic ulcer disease in the past 6 months; - History of arteriovenous thrombosis in the past 6 months; - Severe active infection; - Allergic to any drugs in PDT-ALL-LBL protocol. |
Country | Name | City | State |
---|---|---|---|
China | Department of Hematology, Nanfang Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-Free-Survival | 3 years EFS of LBL/ALL patients enrolled in PDT-ALL-LBL | 3 years | |
Secondary | Minimum residual disease after induction | MRD after induction regimen of PDT-ALL-LBL protocol | 3 months | |
Secondary | CR after Induction Therapy | CR after induction regimen of PDT-ALL-LBL protocol | 3 months | |
Secondary | Death in induction | Dearth during induction regimen of PDT-ALL-LBL | 3 months | |
Secondary | Adverse events | AE of 3 years of LBL patients enrolled in PDT-ALL-LBL | 3 years | |
Secondary | Relapse | Cumulative incidence relapse rate of 3 years of LBL patients enrolled in PDT-ALL-LBL protocol | 3 years | |
Secondary | Relapse free survival | 3 years RFS of LBL patients enrolled in PDT-ALL-LBL protocol | 3 years | |
Secondary | Overall survival | 3 years OS of LBL patients enrolled in PDT-ALL-LBL protocol | 3 years |
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