Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT03599960
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed BPDCN established by a blood or bone marrow immunophenotypic diagnosis by flow cytometric and/or by the anatomic pathology study of a skin biopsy using validated diagnostic criteria (Swerdlow SH CE et al., World Health Organisation Classification of Tumors, 2008; Garnache-Ottou et al., 2009; Angelot et al., 2012; Julia et al., 2014) or patients with confirmed isolated skin lesion.
* 18 years of age or older
* No prior cytotoxic therapy except \<2 week of corticosteroids or hydroxyurea
* ECOG ≤2
* Written informed consent
* Affiliation to the French social security scheme
Exclusion Criteria:
* Cardiac contra-indication to anthracyclines: cardiac dysfunction events (NYHA grade 3 or 4 and/or LVEF\<50%)
* Hepatocellular abnormalities except if considered related to the BPDCN:
1. ASAT (SGOT) and/or ALAT (SGPT) \> 5 x ULN
2. Total bilirubin ≥ 2.5 x ULN
* Creatinine level \>1.5x ULN or creatinine clearance (MDRD)\<50 mL/mn
* Prior thrombotic event
* Active hepatitis B or C virus infection
* HIV positive
* Serious medical or psychiatric illness that could interfere with the completion of treatment
* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
* Pregnant and lactating female patients
* Patients diagnosed with or treated for another malignancy within 2 years before study enrollment or with residual disease (basal cell carcinoma or cervical carcinoma in situ patients may be enrolled if they have undergone complete resection)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03599960
Study Brief:
Protocol Section:
NCT03599960