Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients

Inclusion Criteria

• •Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification:
• •* T/natural killer (NK)-cell leukemia/lymphoma
• •* Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+)
• •* Angioimmunoblastic TCL
• •* Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy
• •* PTCL-unspecified
• •* Enteropathy-type intestinal lymphoma
• •* Hepatosplenic TCL
• •* Subcutaneous panniculitis TCL
• •* Transformed mycosis fungoides (tMF)
• •* Extranodal T/NK-cell lymphoma nasal or nasal type
• •* Primary cutaneous gamma-delta TCL
• •* Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL
• •Documented completion of at least 6 cycles of CHOP-based therapy:
• •* CHOP 21
• •* CHOP 14
• •* CHOP + etoposide
• •* Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization.
• •Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization.
• •Eastern Cooperative Oncology Group performance status less than or equal to 2.
• •Adequate blood, liver, and kidney function as defined by laboratory tests.
• •Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate.
• •Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
• •Has given written informed consent.
• •* Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
• •* Symptomatic central nervous system metastases or lesions requiring treatment.
• •* Uncontrolled hypertension or congestive heart failure Class III/IV per the New York Heart Association's Heart Failure Guidelines
• •* Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment.
• •Major surgery within 2 weeks prior to study entry, except for line placement or biopsy procedure.