Abstract
e18568 Background: Pralatrexate, a targeted antifolate approved for the treatment of recurrent/refractory peripheral T-cell lymphoma, has demonstrated activity in B-cell lymphomas in preclinical models and early clinical trials. Complete tumor regression was observed in pralatrexate-treated mice bearing diffuse large B-cell lymphoma and follicular B-cell xenografts. Partial responses have been observed in patients with B-cell lymphoma in a completed phase I-II study of single-agent pralatrexate and in an ongoing phase I-II study of pralatrexate + gemcitabine. Based on this encouraging research, a phase II trial of PDX-015 has been designed to evaluate pralatrexate in relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) with a primary objective of efficacy. Methods: Patient eligibility includes: (a) histologically/cytologically confirmed, measurable, aggressive B-cell NHL, using the Revised European American Lymphoma World Health Organization disease classification; (b) progressive or persistent disease after at least 1 prior treatment; (c) Eastern Cooperative Oncology Group Performance Status ≤ 2; (d) adequate hematological, hepatic, and renal function; and (e) ≥18 years of age. Pralatrexate is administered with vitamin supplementation at an initial dose of 30 mg/m2/week for 3 weeks in a 4- week cycle. Vitamin supplementation consists of folic acid 1 mg orally daily and vitamin B12 1 mg intramuscularly every 8 to 10 weeks. This study is a 2-stage design, in which ≥1 of the first 13 evaluable patients must respond for a total of 27 evaluable patients to be enrolled. The primary end point is objective response rate per International Workshop Criteria. Secondary objectives include safety, tolerability, and pharmacokinetic profile of pralatrexate in this patient population. Enrollment is ongoing. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Allos Therapeutics Allos Therapeutics Allos Therapeutics
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
