NCT07178457

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin (Bv)	1.8 mg/kg in 100 mlof NaCl 0.9%, Q3W with a maximum of 16 cycles
DRUG	Placebo	NaCl 0.9% 100 ml IV Q3W with a maximum of 16 cycles

Timeline

• Start date: 2025-11-01
• Primary completion: 2032-11-01
• Completion: 2032-11-01
• First posted: 2025-09-17
• Last updated: 2025-09-17