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

Phase 1 Completed 48 enrolled Acrotech Biopharma Inc. Axis Clinicals Limited · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is 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).

Timeline

Start: 2015-11-10
Primary completion: 2017-04-07
Completion: 2020-10-08

Publications

Iyer SP, Johnston PB, Barta SK. Pralatrexate injection combined with CHOP for treatment of PTCL: results from the Fol-CHOP dose-finding phase 1 trial. Blood Adv. 2024 Jan 23;8(2):353-364. doi: 10.1182/bloodadvances.2023011095.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pralatrexate	Other / unclassified	30 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	—	—
Background	Doxorubicin	Other / unclassified	—	—
Background	Prednisone	Other / unclassified	—	—
Background	Vincristine	Small molecule	—	—

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

Summary

Timeline

Publications

Drugs

Indications