Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)

Inclusion Criteria:

Histologic diagnosis of any of the following:

Peripheral T-cell lymphoma not otherwise specified (PTCL-U),(IPI >2)
Angioimmunoblastic T-cell lymphoma (AILT) (IPI >2)
Non-primary cutaneous Alk-1-negative anaplastic large cell lymphoma
Extranodal natural killer (NK)/T lymphoma (Excluding stage I/II nasal disease)
Blastic NK cell lymphoma
Enteropathy type T-cell lymphoma
Cutaneous panniculitis-like T-cell lymphoma
Hepatosplenic T-cell lymphoma
Measurable or assessable disease is not required.
Age ≥ 18 and ≤ 70 years
Previously untreated or 1 prior cycle of chemotherapy
Creatinine < 2.0 mg/dL
Total bilirubin < 2.0 mg/dL, aspartate aminotransferase (AST) < 3x upper limit of normal

Patients who test positive for Hepatitis B surface Ag (HepBSAg) or Hepatitis C antibody (HepCAb) are eligible provided all of the following criteria are met:

bilirubin ≤ 2 x upper limit of normal;
aspartate aminotransferase (AST) ≤ 3 x upper limit of normal;
liver biopsy demonstrates ≤ grade 2 fibrosis and no cirrhosis.

Hepatitis B surface Ag(+) patients will be treated with lamivudine (3TC) or investigator's preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter.

Neutrophils ≥ 1000/microlitre (uL) platelets > 100,000/uL
HIV-negative
Left ventricular ejection fraction (LVEF) of ≥ 45%
No known hypersensitivity to denileukin diftitox or any of its components: diptheria toxin, interleukin-2, or excipients
Non-pregnant, non-nursing: Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible. (This includes Waldenstrom's Macroglobulinemia, since such patents have experienced transient increases inImmunoglobulin M (IgM) following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis). Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse.

Exclusion Criteria:

PTCL-U / AILT with IPI 0 or 1 Extranodal NK/T nasal stage I/II T-lymphoblastic lymphoma Adult T-cell leukemia/lymphoma
Adult T-cell leukemia/lymphoma