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Combination Chemotherapy in Patients With Newly Diagnosed BPDCN

NCT03599960 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-02-08

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • UMR1098, EFS BFC, BESANCON

    collaborator UNKNOWN

  • Centre Henri Becquerel

    collaborator OTHER

  • Maisonneuve-Rosemont Hospital

    collaborator OTHER

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • Inserm CIC1431, CHU Besancon

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2023-02-13
Completion
2024-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599960 on ClinicalTrials.gov