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

NCT02594267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-27

No results posted yet for this study

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).

Conditions

  • Peripheral T-Cell Lymphoma (PTCL)

Interventions

DRUG

Pralatrexate Injection

Drug: Folotyn (Pralatrexate Injection) CHOP : Cyclophosphamide, Doxorubicin, Vincristine, \& Prednisone

Sponsors & Collaborators

  • Axis Clinicals Limited

    collaborator INDUSTRY

  • Acrotech Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Erard Gilles, MD · Navitas Life Sciences Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594267 on ClinicalTrials.gov