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 diagnosis criteria, the Revised European American Lymphoma (REAL), and World Health Organization (WHO) disease classification (PTCL histology/cytology subtypes diagnosed by site investigators, PTCL histology/cytology subtypes rechecked by study central pathology lab):
• •1. At least 5 patients with Peripheral T-cell lymphoma, NOS
• •2. At least 5 patients with Angioimmunoblastic T-cell lymphoma
• •3. At least 5 patients with Extranodal NK/T-cell lymphoma, nasal type
• •4. Enteropathy-type T-cell lymphoma
• •5. Hepatosplenic T-cell lymphoma
• •6. Subcutaneous panniculitis-like T-cell lymphoma
• •7. Adult T-cell lymphoma/leukemia (human T-cell leukemia virus \[HTLV\] 1+)
• •3. Patients with documented progressive disease (PD) failed after prior treatment
• •1. Patients may not have received an experimental drug as their only prior therapy
• •2. Patient has had at least 1 biopsy from initial diagnosis of PTCL or in the relapsed setting to confirm PTCL subtypes
• •3. Patient has recovered from the toxic effects of prior therapy
• •4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• •5. Adequate hematological, hepatic, and renal function as defined by: absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (and ≥ 50,000/µL for any following dose), total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST/ALT \< 5 X ULN if documented hepatic involvement with lymphoma), creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance ≥ 50 mL/min.
• •6. Women of childbearing potential must agree to practice medically acceptable contraceptive 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 negative serum 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) or were surgically sterilized do not require this test.
• •7. Men who are not surgically sterile must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 90 days after the last administration of pralatrexate.
• •8. Patient has provided written informed consent (IC)