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


About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

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

Exclusion Criteria

  1. 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.
  2. Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.
  3. Uncontrolled hypertension
  4. Central nervous system (CNS) metastases .
  5. Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
  6. Major surgery within 30 days prior to enrollment.
  7. Use of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment.
  8. Previous exposure to pralatrexate.
  9. Pregnant or breastfeeding.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Mayo Clinic Footer