Brentuximab Vedotin in CutAneous T-cell Lymphomas (CTCL): Post-allogeneic Hematopoietic Stem Cell Transplant Maintenance

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