A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)

This is a Phase 1, open-label, multicenter, two-part, dose-finding, dose-escalation

study.

The study is divided into two parts:

Part 1

Up to five sequential dose cohorts will enroll a maximum of 6 patients each. Escalation

of the pralatrexate dose, after CHOP administration (Fol-CHOP), will continue in a

traditional 3+3 design, until determination of the MTD. If the MTD is not reached, the

Maximum Administered Dose (MAD) of pralatrexate in combination with CHOP will be 30 mg/m2

IV on Days 1 and 8 of each 21-day cycle for up to 6 cycles.

The first cohort will begin with three patients with dose A and CHOP at full dose. If

none of the first three patients experiences a Dose-Limiting Toxicity (DLT), the next

three patients will be enrolled in next higher dose cohort. If one of the first three

patients in the first cohort experiences DLTs, an additional three patients will be

enrolled into that cohort. If 2 or 3 of the first 3 patients experience DLTs, then the

MTD is not found.

For cohorts 2, 3, 4, and 5, If none of the first three patients experiences a DLT, the

next three patients will be enrolled in next higher dose cohort. If one of the first

three patients in the first cohort experiences DLTs, an additional three patients will be

enrolled into that cohort. If 2 or 3 of the first 3 patients experience DLTs, then the

previous cohort will be considered the MTD and up to an additional 10 patients will be

enrolled at that dose in Part 2 of the study.

Part 2

Once the MTD for the Fol-CHOP regimen has been established in Part 1 of the study, an

additional 10 patients will be treated at the MTD (or MAD if MTD not reached) to confirm

tolerability. Additionally, the PK of the established MTD of pralatrexate, when

administered with CHOP at full dose, will be evaluated in these 10 patients.