A Phase 1, Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients with Peripheral T-Cell Lymphoma (PTCL)
The goal of this clinical research study is to find the highest tolerable dose of pralatrexate (Folotyn) that can be given in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with PTCL.
Treatment Location: N/A
Primary Objective: 1) To evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL). Secondary Objectives: 1) To evaluate the safety and tolerability of pralatrexate in combination with CHOP (Fol- CHOP). 2) To evaluate the Objective Response Rate (ORR) of 6 cycles of Fol-CHOP. 3)To evaluate the pharmacokinetics (PK) of pralatrexate when given in combination with CHOP.
IRB Review and Approval Date: 02/09/2016
Recruitment Status: Closed
Projected Accrual: N/A
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