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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
1.8 mg/kg in 100 mlof NaCl 0.9%, Q3W with a maximum of 16 cycles
NaCl 0.9% 100 ml IV Q3W with a maximum of 16 cycles
Progression Free Survival
Time frame: 2 years after randomization
Overall survival
Time frame: 2 years after randomization
Quality of life scoring
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a 30-item scale with scores ranging from 0 to 100. A higher score indicates better quality of life.
Time frame: At 1 year
Quality of life scoring
The Skindex-29 is a 29-item questionnaire assessing the impact of skin diseases on quality of life, with scores ranging from 0 to 100. Higher scores indicate greater impairment in quality of life.
Time frame: At 1 year
Cumulative incidence of disease relapse
Time frame: At 2 years
Cumulative incidence of acute graft-versus-host disease (GVHD)
Time frame: At 2 years
Cumulative incidence of chronic GVHD
Time frame: At 2 years
Cumulative incidence of non-relapse mortality
Time frame: At 2 years
Quality of life scoring
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a 30-item scale with scores ranging from 0 to 100. A higher score indicates better quality of life.
Time frame: At 2 years
Quality of life scoring
The Skindex-29 is a 29-item questionnaire assessing the impact of skin diseases on quality of life, with scores ranging from 0 to 100. Higher scores indicate greater impairment in quality of life.
Time frame: At 2 years
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