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

This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.

NCT Number	NCT06724237
Lead Sponsor	Eastern Cooperative Oncology Group Collaborators: National Cancer Institute (NCI)
Conditions	Anaplastic Large Cell Lymphoma, ALK-Negative, Follicular Helper T-Cell Lymphoma, Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type, Peripheral T-Cell Lymphoma, Not Otherwise Specified
Enrollment	294 participants
Start Date	2025-01-30
Primary Completion	2028-04-30 (estimated)
Study Completion	2033-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-17