Status:
NOT_YET_RECRUITING
Brentuximab Vedotin in CutAneous T-cell Lymphomas (CTCL): Post-allogeneic Hematopoietic Stem Cell Transplant Maintenance
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cutaneous T Cell Lymphoma (CTCL)
Brentuximab Vedotin
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Allogeneic hematopoietic stem cell transplantation (alloHSCT) showed efficacy in advanced-stage, high-risk, treatment sensitive cutaneous T-cell lymphomas (CTCL) in a prospective, propensity score-mat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07178457
Start Date
November 1 2025
End Date
November 1 2032
Last Update
September 17 2025
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