A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

Inclusion Criteria:

1. At least 20 years of age, inclusive

2. Patients with histologically/cytologically confirmed PTCL using either: NCCN diagnosiscriteria, the Revised European American Lymphoma (REAL), and World Health Organization (WHO) disease classification (PTCL histology/cytology subtypes diagnosed by siteinvestigators, PTCL histology/cytology subtypes rechecked by study central pathologylab):

3. At least 5 patients with Peripheral T-cell lymphoma, NOS

4. At least 5 patients with Angioimmunoblastic T-cell lymphoma

5. At least 5 patients with Extranodal NK/T-cell lymphoma, nasal type

6. Enteropathy-type T-cell lymphoma

7. Hepatosplenic T-cell lymphoma

8. Subcutaneous panniculitis-like T-cell lymphoma

9. Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)

10. Patients with documented progressive disease (PD) failed after prior treatment

11. Patients may not have received an experimental drug as their only prior therapy

12. Patient has had at least 1 biopsy from initial diagnosis of PTCL or in therelapsed setting to confirm PTCL subtypes

13. Patient has recovered from the toxic effects of prior therapy

14. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

15. Adequate hematological, hepatic, and renal function as defined by: absolute neutrophilcount (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (and ≥ 50,000/µL for any followingdose), total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST) and alanineaminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST/ALT < 5 X ULN ifdocumented hepatic involvement with lymphoma), creatinine ≤ 1.5 mg/dL or a calculatedcreatinine clearance ≥ 50 mL/min.

16. Women of childbearing potential must agree to practice medically acceptablecontraceptive regimen from 30 days prior to study treatment initiation until at least 30 days after the last administration of pralatrexate and must have had a negativeserum pregnancy test within 14 days prior to the first day of study treatment.Patients who are postmenopausal for at least 1 year (> 12 months since last menses) orwere surgically sterilized do not require this test.

17. Men who are not surgically sterile must agree to practice a medically acceptablecontraceptive regimen from study treatment initiation until at least 90 days after thelast administration of pralatrexate.

18. Patient has provided written informed consent (IC)

Exclusion Criteria:

1. Patient has following subtypes (histologically/cytologically confirmed) of PTCL

2. Anaplastic large cell lymphoma, ALK +/-

3. Patient has: Precursor T/NK neoplasms, with the exception of blastic NK lymphoma

4. T-cell prolymphocytic leukemia (T-PLL)

5. T-cell large granular lymphocytic leukemia

6. Mycosis fungoides and transformed mycosis fungoides

7. Sézary syndrome

8. Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma andlymphomatoid papulosis

9. Patient has: Extranodal NK/T-cell lymphoma, nasal type with local recurrence

10. Active concurrent malignancy (except for non-melanoma skin cancer or carcinoma in situof the cervix). If there is a history of prior malignancy, the patient must bedisease-free for ≥ 5 years.

11. Congestive heart failure Class III/IV according to the New York Heart Association'sHeart Failure guidelines.

12. Patients with human immunodeficiency virus (HIV)-positive diagnosis and are receivingcombination anti-retroviral therapy.

13. Current or the history of brain metastases or central nervous system (CNS) diseases

14. Have undergone allogeneic stem cell transplant

15. Relapsed less than 75 days from time of autologous stem cell transplant

16. Patients with uncontrolled hypertension, active uncontrolled infection, underlyingmedical condition including unstable cardiac disease, or other serious illness thatwould impair the ability of the patient to receive protocol treatment

17. Had major surgery within 2 weeks of study entry

18. Receipt of any conventional chemotherapy or radiation therapy (RT) within 4 weeks (6weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use duringthe course of the study

19. Receipt of corticosteroids within 7 days of study treatment, unless patient has beentaking a stable dose of no more than 10 mg/day of prednisone for at least 1 month

20. Use of any investigational drug, biologic modifier, or device within 4 weeks prior tostudy treatment or planned use during the course of the study

21. Previous exposure to pralatrexate

22. Other conditions that investigators consider not suitable for study enrollment