Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Histologically/cytologically confirmed PTCL, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification:

1. T/Natural Killer (T/NK) cell leukemia/lymphoma

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

3. Angioimmunoblastic T cell lymphoma

4. Blastic Natural Killer (NK) lymphoma (with skin, lymph node, or visceral involvement)

5. Anaplastic large cell lymphoma, primary systemic type

6. PTCL - unspecified

7. T/NK-cell lymphoma - nasal

8. Enteropathy-type intestinal lymphoma

9. Hepatosplenic T cell lymphoma

10. Extranodal peripheral T/NK-cell lymphoma - unspecified

11. Subcutaneous panniculitis T-cell lymphoma

12. Transformed mycosis fungoides

Documented progression of disease after at least 1 prior treatment. Patients may not have received experimental therapy as their only prior therapy. 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. Patients treated with monoclonal antibody therapy may be enrolled regardless of the time frame of the therapy if they have progression of disease.

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

≥ 18 years of age.

Adequate hematological, hepatic, and renal function.

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 or are surgically sterilized do not require this test.

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.

Patient has given written informed consent.

What this study is about