Combination Chemotherapy in Patients With Newly Diagnosed BPDCN

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 2, 2019

Primary Completion Date

February 13, 2023

Study Completion Date

November 30, 2024

Conditions
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Interventions
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)"

Trial Locations (2)

25030

Chu Besancon, Besançon

80090

Clinique de L'Europe, Amiens

All Listed Sponsors
collaborator

UMR1098, EFS BFC, BESANCON

UNKNOWN

collaborator

Centre Henri Becquerel

OTHER

collaborator

Maisonneuve-Rosemont Hospital

OTHER

collaborator

Centre Hospitalier Universitaire Dijon

OTHER

collaborator

Inserm CIC1431, CHU Besancon

UNKNOWN

lead

Centre Hospitalier Universitaire de Besancon

OTHER

NCT03599960 - Combination Chemotherapy in Patients With Newly Diagnosed BPDCN | Biotech Hunter | Biotech Hunter