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

Completed · Phase 1

Conditions studied: Peripheral T-Cell Lymphoma (PTCL)

In brief

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).

Key facts

Study ID

NCT02594267

Run by

Acrotech Biopharma Inc.

People needed

48

Starts

2015-11-10

Expected to finish

2020-10-08

Last updated by the study team

2021-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or above
• Adequate hematologic, hepatic, and renal function
• Histologically confirmed, new diagnosis of PTCL
• Eligible for CHOP regimen
• Measurable disease based on Cheson 2007 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status < 2
• Willing to perform at least two methods of contraception
• Negative pregnancy test of females with childbearing potential.

You may not qualify if…

• Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life threatening disease. If there is a history of prior malignancies or life threatening diseases, the patient must be disease free for at least 5 years.
• Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.
• Uncontrolled hypertension
• Central nervous system (CNS) metastases .
• Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
• Major surgery within 30 days prior to enrollment.
• Use of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment.
• Previous exposure to pralatrexate.
• Pregnant or breastfeeding.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• MD Anderson — Houston, Texas, United States
• Seattle Cancer Care Alliance/University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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