Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)
Condition: Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Gemcitabine; Navelbine; Doxorubicin Hydrochloride Liposome Injection; Granulocyte-colony stimulating factor (G-CSF); Pegfilgrastim; Cyclophosphamide; Vincristine; Leucovorin; Methotrexate; Doxorubicin Hydrochloride; Cytarabine; Etoposide; Carmustine; Denileukin diftitox
Intervention description: Chemotherapy medication used to treat a number of types of cancer; Navelbine is an chemotherapy medication used to treat a number of types of cancer; Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug; G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.; Colony-stimulating factor 3 (CSF 3) and, is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. May be used instead of G-CSF; Cancer medication that interferes with the growth and spread of cancer cells in the body; Vincristine is a chemotherapy medication used to treat cancer. Vincristine works by stopping the cancer cells from separating into 2 new cells to stops the growth of the cancer; Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer.; Methotrexate is a chemotherapy medication used to treat cancer; Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer; Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma; Etoposide is a is a chemotherapy medication used to treat cancer; Carmustine is a chemotherapy medication used to treat cancer; Denileukin diftitox is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. Denileukin diftitox could bind to Interleukin-2 receptors and introduce the diphtheria toxin into cells that express those receptors, killing the cells
Intervention MeSH terms: Leucovorin; Cytarabine; Cyclophosphamide; Carmustine; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Methotrexate; Etoposide; Vincristine; Vinorelbine; Denileukin diftitox; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study examines the use of denileukin diftitox (Ontak) for patients with peripheral
      T-cell lymphoma who are candidates for autologous stem cell transplants.
    

Eligibility criteria:

        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