BRENTUXIMAB VEDOTIN for Cutaneous T-cell lymphoma | Mycosis fungoides

Inclusion criteria

• {"criterion_text":"- (i) Age ≥ 18 and ≤ 70 years\n- (ii) Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry\n- (iii) ECOG performance status 0-1\n- (iv) Relapsed or refractory to at least one line of systemic treatment\n- (v) Complete or partial response of the lymphoma at the time of study inclusion\n- (vi) Having received recent alloHSCT from a sibling, 10/10 or 9/10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion)\n- (vii) 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 (viii) Adequate hematological function: • Absolute neutrophil count of ≥ 1.0 G/L • Platelet count of ≥ 50 G/L • Hemoglobin ≥ 9 g/dL\n- (ix) Adequate renal function: creatinine clearance calculated by Cockcroft & Gault formula of ≥ 50 mL/min\n- (x) Patient affiliated to life insurance\n- (xi) Written informed consent given by the patient"}

Exclusion criteria

• {"criterion_text":"- (i) Second or higher allogeneic HSCT\n- (ii) Other progressive neoplastic or psychotic disease\n- (iii) Left ventricular ejection fraction < 50%, carbone monoxide diffusion capacity < 50% of the theoretical value\n- (iv) 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\n- (v) 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.\n- (vi) History of ≥ grade 4 adverse event induced by BV. Previous \n- (vii) Contra-indication to BV including current >grade 2 neutropenia or active infection\n- (viii) Progressive disease or relapse at study inclusion compared to the screening visit status\n- (ix) Refusal of two highly effective birth control methods for female participant of childbearing potential and male participant with a female partner of childbearing potential\n- (x) Pregnant and/or breastfeeding women\n- (xi) Participation to another interventional clinical trial\n- (xii) Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice\n- (xiii) Patients deprived of their liberty by a judicial or administrative decision"}

Primary endpoints

• {"endpoint_text":"- The main study endpoint is progression-free survival at 2 years after randomization. Progression/relapse will be defined according to the ISCL/EORTC criteria, and assessed in a double-blind setting.","definition_or_measurement_approach":"Progression-free survival at 2 years after randomization; progression/relapse defined according to the ISCL/EORTC criteria; assessments performed in a double-blind setting."}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS)\n- 1-year variation in quality-of-life scores (EORTC- QLQ-C30 & Skindex-29)\n- Cumulative incidence of disease relapse\n- Cumulative incidence of acute graft-versus-host disease (GVHD)\n- Cumulative incidence of chronic GVHD\n- Cumulative incidence of non-relapse mortality\n- 2-year variation in quality-of-life scores (EORTC-QLQ-C30 and Skindex-29)\n- Skin tumour microenvironment at baseline, 3 months and at relapse/progression if any","definition_or_measurement_approach":"Overall survival measured as time from randomization to death (OS). Quality of life measured by EORTC-QLQ-C30 and Skindex-29 at 1 year and 2 years. Relapse and graft-versus-host disease endpoints measured as cumulative incidence. Skin tumour microenvironment assessed at baseline, 3 months and at relapse/progression."}

France

Earliest CTIS Part Ii Submission Date

16-06-2025

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

269

Number Of Sites

21

Number Of Participants

84

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France