NCT03599960

Combination Chemotherapy in Patients With Newly Diagnosed BPDCN

Combination Chemotherapy (Methotrexate, L-asparaginase, Idarubicin and Dexamethasone) in Patients With Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Interventions

Type	Name	Description
DRUG	Chemotherapy	* Idarubicin 12mg/m2 IV at D1 * Methotrexate at D1 (24H infusion, alkaline hydration, leucovorin rescue): * Patients \<65y and albuminemia \>35 g/l and CrCl (MDRD)\>60 ml/min: 3000 mg/m² * Patients \<65y and albuminemia \<35 g/l and/or CrCl (MDRD) \<60 ml/min: 1000 mg/m² IV * Patients ≥65y and albuminemia \>35 g/l and CrCl (MDRD) \> 60 ml/min : 1000 mg/m² * Patients ≥ 65y and albuminemia \< 35 g/l and/or CrCl (MDRD) \< 60 ml/min : 500 mg/m² * L-asparaginase (SPECTRILA) : 5000 units/m² IV at D2, 5, 8, 11 (switch to Erwinia asparaginase/Cirsantaspase 25 000 U/m² with the same drug regimen in case of hypersensitivity reactions or significant diminution of asparaginase activity) * Dexamethasone 40mg PO or IV at D1-4 (dose diminution at 20 mg for Age ≥65y)

Timeline

• Start date: 2019-05-02
• Primary completion: 2023-02-13
• Completion: 2024-11-01
• First posted: 2018-07-26
• Last updated: 2024-02-08

Locations

2 sites across 1 country: France