drugset / Trial / NCT03564704
Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-02-14
- Primary completion
- 2021-05-30
- Completion
- 2021-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucidinostat | Small molecule | 10 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 1 g | — |
| Background | Cytarabine | Small molecule | 3 g | — |
| Background | Dexamethasone | Small molecule | 10 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Etoposide | Small molecule | — | — |
| Background | Idarubicin | Small molecule | — | — |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Background | Methotrexate | Small molecule | 5 g | — |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 iu | — |
| Background | Vincristine | Small molecule | — | — |