| Inclusion Criteria: | 1) Patient has histologically/cytologically confirmed PTCL, using the Revised European American Lymphoma (REAL) WHO disease classification: (a) T/NK-cell leukemia/lymphoma; (b) Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+); (c) Angioimmunoblastic T-cell lymphoma; (d) Blastic NK lymphoma (with skin, lymph node, or visceral involvement); (e) Anaplastic large cell lymphoma, primary systemic type; (f) PTCL – unspecified; (g) T/NK-cell lymphoma – nasal; (h) Enteropathy-type intestinal lymphoma; (i) Hepatosplenic T-cell lymphoma; (continued in Incl. #2)
2) (continued from # 1): (j) Extranodal peripheral T/NK-cell lymphoma – unspecified; (k) Subcutaneous panniculitis T-cell lymphoma; (l) Transformed mycosis fungoides.
3) Patient has documented progression of disease after at least 1 prior treatment. Patients may not have received experimental drugs or biologics as their only prior therapy. Patient must have clear disease progression after the last treatment received. Patient has at least 1 biopsy from initial diagnosis or in the relapsed setting to confirm the diagnosis of PTCL. Patient has recovered from the toxic effects of prior therapy. (continued in Incl. # 4).
4) (Continued from Incl. # 3): Patients treated with Food and Drug Administration (FDA) approved monoclonal antibody therapy may be enrolled regardless of the time frame of the therapy if they have progression of disease.
5) ECOG Performance Status </= 2.
6) At least 18 years of age.
7) Adequate hematological, hepatic, and renal function as defined by: ANC >/= 1000/microL, platelet count >/= 100,000/microL (at both screening and within 3 days prior to dosing on Cycle 1, Day 1), total bilirubin </= 1.5 mg/dL, aspartate aminotransferase (AST) and ALT </= 2.5 × ULN, (AST/ALT < 5 × ULN if documented hepatic involvement with lymphoma), creatinine </= 1.5 mg/dL (if the patient's creatinine is > 1.5 mg/dL then the calculated creatinine clearance must be >/= 50 mL/min).
8) Women of childbearing potential must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate and must have 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 are surgically sterilized do not require this test.
9) 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.
10) Patient has given written informed consent (IC). |