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

NCT07178457 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: APHP241010
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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-matched controlled study (CUTALLO) published by our group in the Lancet in 2023. Nevertheless, it is associated with a high rate of early relapse, with 2-year progression-free survival around 30%. Brentuximab vedotin (BV) has shown efficacy in the treatment of CD30-expressing CTCL after at least one prior systemic treatment in the ALCANZA trial and is market approved in this indication in Europe and the United States of America. BV has been successfully used as salvage treatment in the post-transplant setting in advanced CTCL. It has been shown that 90% of CTCL express CD30. To reduce the incidence of post-allograft relapse, we propose to assess the routine use of BV post-allograft in adult patients with advanced CD30-expressing mycosis fungoides-CTCL, who have received at least one line of prior systemic therapy, compared to placebo. Switch will be allowed from placebo to BV in case of disease progression. This project is supported by well-organized research networks with a strong track-record of published results in the field: French Study Group on Cutaneous Lymphomas (GFELC, Groupe Français d'Etude des Lymphomes Cutanés), INCa-labelled national rare cancers network; and the French Society of Bone Marrow Transplantation and CellTherapy. In the post-transplant setting, the current state-of-the-art practice is to treat patients once they have relapsed post-allogeneic transplant, whereas no prophylactic treatment is given at the time in the absence of characterized disease relapse. This ethically and scientifically justifies the proposal to evaluate whether earlier, prophylactic treatment with BV increases progression-free survival compared to placebo.

Conditions

Cutaneous T Cell Lymphoma (CTCL); Brentuximab Vedotin

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  2 years after randomization

Secondary Outcomes (9)

• Overall survival

  2 years after randomization

• Quality of life scoring

  At 1 year

• Quality of life scoring

  At 1 year

• Cumulative incidence of disease relapse

  At 2 years

• Cumulative incidence of acute graft-versus-host disease (GVHD)

  At 2 years

Study Arms (2)

Brentuximab vedotin

EXPERIMENTAL

Drug: Brentuximab Vedotin (Bv)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Brentuximab Vedotin (Bv) DRUG

1.8 mg/kg in 100 mlof NaCl 0.9%, Q3W with a maximum of 16 cycles

Brentuximab vedotin

Placebo DRUG

NaCl 0.9% 100 ml IV Q3W with a maximum of 16 cycles

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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,
• Contra-indication to BV including current \>grade 2 neutropenia or active infection,
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Central Study Contacts

Adèle de Masson, MD PhD

CONTACT

+33 (0)1 71 20 75 01; adele.demasson@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, prospective, double-blind, placebo-controlled, (ratio 1:1) randomized study, with randomization stratified on donor type, previous use of BV or not and Complete Response (CR)/Partial Response (PR)/Stable disease (SD) after 1st course of BV

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: September 17, 2025

Record last verified: 2025-09