Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL

• Status: Unknown status
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: 6-Mercaptopurine; BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone acetate; Doxorubicin; Etoposide; Etoposide phosphate; Histone Deacetylase Inhibitors; Idarubicin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Pegaspargase; Vincristine

Criteria

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.