Combination Chemotherapy in Patients With Newly Diagnosed BPDCN
Summary
Patients with suspected BPDCN and meeting eligibility criteria will be enrolled in the study. First, BPDCN diagnosis will be confirmed by anatomic pathology (Dr Petrella T, Montreal) and cytologic plus immunophenotyping analysis (Pr Garnache Ottou F, UMR1098 BESANCON). Patients will then receive three 21 days cycles of a combination of chemotherapy (Ida/Metho/L-asp/Dex), followed by an evaluation. Patients with complete response (CR) or complete response with incomplete bone marrow recovery (CRi) will undergo an allo- or auto-SCT and those who are not eligible to the transplantation will have successive 28 days cycles of chemotherapy (Metho/L-asp/Dex). Patients who did not respond to the treatment will be treated by physicians. All patients will be followed for 24 months.
Timeline
- Start
- 2019-05-02
- Primary completion
- 2023-02-13
- Completion
- 2024-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asparaginase Erwinia chrysanthemi | Protein / enzyme biologic | 25000 unknown | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 3000 mg/m2 | Intravenous |
| Subject | asparaginase | Protein / enzyme biologic | 5000 unknown | Intravenous |
| Background | Leucovorin | Small molecule | — | — |