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BeCALM - Brentuximab vedotin in CutAneous T-cell Lymphomas (CTCL): post-allogeneic hematopoietic stem cell transplant Maintenance
EU CTIS ID: 2025-521093-34-00
What this study is testing
The main objective is to compare the progression-free survival rate post alloHSCT in the BV group compared to placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- (i) Age ≥ 18 and ≤ 70 years
- (ix) Adequate renal function: creatinine clearance calculated by Cockcroft & Gault formula of ≥ 50 mL/min
- (ii) Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry
- (iv) Relapsed or refractory to at least one line of systemic treatment
- (v) Complete or partial response of the lymphoma at the time of study inclusion
- (vi) Having received recent alloHSCT from a sibling, 10/10 or 9/10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion)
You likely can't join if
- (i) Second or higher allogeneic HSCT
- (x) Pregnant and/or breastfeeding women
- (xi) Participation to another interventional clinical trial
- (xii) Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice
- (xiii) Patients deprived of their liberty by a judicial or administrative decision
- (ii) Other progressive neoplastic or psychotic disease
See the full eligibility criteria
- (i) Age ≥ 18 and ≤ 70 years
- (ix) Adequate renal function: creatinine clearance calculated by Cockcroft & Gault formula of ≥ 50 mL/min
- (ii) Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry
- (iv) Relapsed or refractory to at least one line of systemic treatment
- (v) Complete or partial response of the lymphoma at the time of study inclusion
- (vi) Having received recent alloHSCT from a sibling, 10/10 or 9/10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion)
- (x) Patient affiliated to life insurance
- (xi) Written informed consent given by the patient
- (iii) ECOG performance status 0-1
- (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
- (i) Second or higher allogeneic HSCT
- (x) Pregnant and/or breastfeeding women
- (xi) Participation to another interventional clinical trial
- (xii) Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice
- (xiii) Patients deprived of their liberty by a judicial or administrative decision
- (ii) Other progressive neoplastic or psychotic disease
- (iii) Left ventricular ejection fraction < 50%, carbone monoxide diffusion capacity < 50% of the theoretical value
- (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
- (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.
- (vi) History of ≥ grade 4 adverse event induced by BV. Previous
- (vii) Contra-indication to BV including current >grade 2 neutropenia or active infection
- (viii) Progressive disease or relapse at study inclusion compared to the screening visit status
- (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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.