Study Comparing Chemotherapy Alone Versus Chemotherapy Plus Autologous Stem Cell Transplant in Adults With Peripheral T-Cell Lymphoma Who Achieve Complete Response

What this Trial Is About

Peripheral T-cell lymphoma PTCL includes several mature T-cell lymphoma subtypes, such as angioimmunoblastic T-cell lymphoma and others, which together make up about 20 to 25% of mature T- and NKT-cell lymphomas. These lymphomas generally have a poor prognosis compared to B-cell lymphomas, with a 10-year survival rate around 30% except for ALK-positive anaplastic large cell lymphoma. There is no clear consensus on the best first-line treatment for most PTCL types, and the role of autologous stem cell transplantation ASCT as consolidation after chemotherapy response remains debated. Patients in this study receive chemotherapy every three weeks for six cycles, with regimens chosen by the local investigator based on standard practices. Chemotherapy options include CHOP, CHOEP, or BV-CHP for ALCL lymphoma. Those achieving a complete response after chemotherapy may be randomized to receive ASCT consolidation with a high-dose therapy conditioning regimen called BEAM, which lasts 2 to 3 months. Evaluations with PET-CT or CT scans occur after four cycles, post-induction, and again 8 to 12 weeks after post-induction. Participants will undergo multiple scans and assessments to monitor disease status and treatment effects, including metabolic tumor volume and response evaluation by PET-CT. The main outcome measured is progression-free survival after ASCT. Secondary outcomes include overall survival, response rates, duration of response, time to next treatment, quality of life, and cost-effectiveness. The study follows patients for at least two years after randomization or until key events such as progression or relapse occur.

Transplantation After Complete Response In Patients With T-cell Lymphoma