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:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT07178457
Eligibility Criteria:
Inclusion Criteria:
To be eligible for study entry, patients must meet all of the following criteria:
* Age ≥ 18 and ≤ 70 years
* Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry
* ECOG performance status 0-1
* Relapsed or refractory to at least one line of systemic treatment
* Complete or partial response of the lymphoma at the time of study inclusion
* Having received recent alloHSCT from a sibling, 10/10 or 9/10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion)
* Adequate liver function:
* Total bilirubin ≤ 2 xULN, or Direct bilirubin ≤ 2xULN if total bilirubin is \>2xULN, or total bilirubin \>2 xULN if elevated total bilirubin is attributed to Gilbert's syndrome
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
* Adequate hematological function:
* Absolute neutrophil count of ≥ 1.0 G/L
* Platelet count of ≥ 50 G/L
* Hemoglobin ≥ 9 g/dL
* Adequate renal function: creatinine clearance calculated by Cockcroft \& Gault formula of ≥ 50 mL/min
* Patient affiliated to life insurance
* Written informed consent given by the patient
Exclusion Criteria:
Any of the following criteria requires the exclusion of the patient before randomization:
* Second or higher allogeneic HSCT,
* Other progressive neoplastic or psychotic disease,
* Left ventricular ejection fraction \< 50%, carbone monoxide diffusion capacity \< 50% of the theoretical value,
* History of BV-induced adverse event without resolution to current grade \<2. Previous treatment with brentuximab vedotin alone, in the absence of current ≥ grade 2 BV-induced side effect, is NOT an exclusion criterion.
* History of disease refractoriness, progression or relapse during BV treatment. Previous treatment with BV alone, if the disease was treatment-sensitive (complete, partial response or stable disease), is NOT an exclusion criterion.
* History of ≥ grade 4 adverse event induced by BV. Previous \<grade 4 adverse event induced by BV is not an exclusion criterion if the adverse event has regressed to grade\<2.
* Contra-indication to BV including current \>grade 2 neutropenia or active infection,
* Progressive disease or relapse at study inclusion compared to the screening visit status,
* Refusal of highly effective birth control method for female participant of childbearing potential and male participant with a female partner of childbearing potential,
* Pregnant and/or breastfeeding women,
* Participation to another interventional clinical trial,
* Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice),
* Patients deprived of their liberty by a judicial or administrative decision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07178457
Study Brief:
Protocol Section:
NCT07178457