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.

Exclusion Criteria:

Patient has:

Precursor T/NK neoplasms
ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy
T cell prolymphocytic leukemia
T cell large granular lymphocytic leukemia
Mycosis fungoides, except tMF
Sézary syndrome
Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis

If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease.

non-melanoma skin cancer
carcinoma in situ of the cervix
localized prostate cancer
localized thyroid cancer

Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:

Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization.
Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.
Prior exposure to pralatrexate.
Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper.
Planned use of any treatment for PTCL during the course of the study.

Patient has:

Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and receiving anti-retroviral therapy.
Hepatitis B (HBV)-positive serology and is receiving interferon therapy or has liver function test results outside the parameters of study inclusion criteria. Other antiviral therapies are permitted if at a stable dose for at least 4 weeks.
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.