drugset / Trial / NCT04446130
Study of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers Patients
Phase 3
Unknown
100 enrolled
The First Affiliated Hospital of Soochow University
Changzhou No.2 People's Hospital · collabHenan Cancer Hospital · collabShandong Provincial Hospital · collabShenzhen People's Hospital · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collabThe First Affiliated Hospital of Anhui Medical University · collabThe Second People's Hospital of Huai'an · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of decitabine combined with HAAG regimen in the treatment of newly diagnosed patients with ETP-ALL/LBL, T/M-MPAL and ALL/LBL with myeloid or stem cell markers.
Timeline
- Start
- 2019-01-01
- Primary completion
- 2023-01-01
- Completion
- 2024-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclarubicin | Small molecule | 10 mg | Intravenous |
| Subject | Cytarabine | Small molecule | 10 mg/m2 | Subcutaneous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Homoharringtonine | Small molecule | 1 mg | Intravenous |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 50 ug | Subcutaneous |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 300 ug | Subcutaneous |