Phase III Study Comparing Autologous Stem Cell Transplant Versus Observation in Adults With Peripheral T-Cell Lymphoma in First Complete Remission

What this Trial Is About

This trial investigates whether high dose chemotherapy followed by an autologous stem cell transplant ASCT improves progression-free survival compared to observation alone in patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy. The study also evaluates overall survival, relapse, mortality, and the impact of minimal residual disease on transplant benefits. This phase III randomized trial aims to clarify if adding ASCT after remission offers additional benefit beyond standard observation. Participants are randomly assigned to one of two groups. One group receives standard observation including blood sample collection and optional bone marrow tests, along with CT or PETCT scans throughout the study. The other group undergoes stem cell mobilization, leukapheresis, high dose chemotherapy, and ASCT, with similar sample collections and imaging. After treatment, patients are followed for up to 12 years to monitor outcomes. During the study, participants have regular blood tests, optional bone marrow biopsies, and imaging scans to assess disease status. Follow-up visits occur every 3 months for 2 years, then every 6 months for 3 years, and yearly thereafter. Researchers measure progression-free survival as the main outcome, along with overall survival and relapse rates. Safety and long-term effects are monitored throughout the 12-year observation period to evaluate the treatments impact.

Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy