Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).
Study Type
OBSERVATIONAL
Enrollment
98
Hematopoietic stem cell transplantation
Saint Louis hospital
Paris, France
Progression-Free Survival (PFS)
Time frame: 3 year
overall survival (OS)
Time frame: 3 year
Neutrophils Engraftment
Neutrophils \> 1,000 Giga/L
Time frame: 180 days
Acute and chronic graft-versus-host disease (GVHD)
Time frame: 180 days
Cumulative incidence of relapse
Time frame: 3 years
Treatment-related mortality (TRM)
Time frame: 12 months
Quality of life (QoL)
Time frame: 3 years
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