OBJECTIVES: The objective of this study was to review the trends in design of pivotal clinical trials for Peripheral T-Cell Lymphoma. METHODS: Systematic review was conducted to identify new and on-going pivotal clinical for Peripheral T-Cell Lymphoma. The inclusion criteria were the indication of Peripheral T-Cell Lymphoma and study completion date of 2005 or after. The data field extracted were study title, intervention, sponsor, age subgroups, planned enrollment, study type, study design, completion date and outcome measures. RESULTS: Overall, 7 Phase III clinical studies with total planned enrollment of 1386 patients were identified. The median enrollment for the studies was 271 patients. Six of the seven studies were for drugs, one study was for a biologic. The largest Phase III study with 420 patients is sponsored by The Lymphoma Academic Research Organization. The common primary outcome measures were Event free survival and Progression Free Survival (PFS). Other primary outcome measures included: overall response rate and overall survival (OS, only 1 study). The secondary outcomes included: rate of complete and partial remissions, OS (multiple trials), response rate at the end of the treatment, PFS (multiple trials), transplant rate, (multiple trials), complete response + complete response unconfirmed and FACT-lym. Four of the seven studies were sponsored by academia, while others were sponsored by the industry. CONCLUSIONS: This review provides an overview of on-going and future Phase III clinical trials for Peripheral T-Cell Lymphoma. Study findings might be useful for design and conduct of new studies.