BeCALM - Brentuximab vedotin in CutAneous T-cell Lymphomas (CTCL): post-allogeneic hematopoietic stem cell transplant Maintenance

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-08-19

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

French Ministry of Health (DGOS)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The main objective is to compare the progression-free survival rate post alloHSCT in the BV group compared to placebo.

Secondary objectives 2

1. To assess the effect of alloHSCT in terms of overall survival, quality of life, cumulative incidence of relapse, of graft-versus-host disease, of treatment-related mortality.
2. To study the tumour microenvironment under treatment and at relapse if any.

Conditions and MedDRA coding

rare disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. (i) Age ≥ 18 and ≤ 70 years
2. (ii) Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry
3. (iv) Relapsed or refractory to at least one line of systemic treatment
4. (v) Complete or partial response of the lymphoma at the time of study inclusion
5. (vi) Having received recent alloHSCT from a sibling, 10/10 or 9/10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion)
6. (x) Patient affiliated to life insurance
7. (xi) Written informed consent given by the patient
8. (iii) ECOG performance status 0-1
9. (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
10. (ix) Adequate renal function: creatinine clearance calculated by Cockcroft & Gault formula of ≥ 50 mL/min

Exclusion criteria 13

1. (i) Second or higher allogeneic HSCT
2. (ii) Other progressive neoplastic or psychotic disease
3. (iii) Left ventricular ejection fraction < 50%, carbone monoxide diffusion capacity < 50% of the theoretical value
4. (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
5. (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.
6. (vi) History of ≥ grade 4 adverse event induced by BV. Previous
7. (vii) Contra-indication to BV including current >grade 2 neutropenia or active infection
8. (viii) Progressive disease or relapse at study inclusion compared to the screening visit status
9. (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
10. (x) Pregnant and/or breastfeeding women
11. (xi) Participation to another interventional clinical trial
12. (xii) Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice
13. (xiii) Patients deprived of their liberty by a judicial or administrative decision

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 8

1. Overall survival (OS)
2. 1-year variation in quality-of-life scores (EORTC- QLQ-C30 & Skindex-29)
3. Cumulative incidence of disease relapse
4. Cumulative incidence of acute graft-versus-host disease (GVHD)
5. Cumulative incidence of chronic GVHD
6. Cumulative incidence of non-relapse mortality
7. 2-year variation in quality-of-life scores (EORTC-QLQ-C30 and Skindex-29)
8. Skin tumour microenvironment at baseline, 3 months and at relapse/progression if any

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Caroline RAM WOLFF

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Caroline RAM WOLFF

Locations

1 EU/EEA country · 21 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications