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

• Status: Terminated
• Trial end date: 2016-06-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Eisai Inc.; Roswell Park Cancer Institute; University of Chicago; University of North Carolina; Wake Forest School of Medicine; Washington University Early Recognition Center; Washington University School of Medicine; Weill Medical College of Cornell University
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Denileukin diftitox; Doxorubicin; Etoposide; Gemcitabine; Interleukin-2; Lenograstim; Leucovorin; Liposomal doxorubicin; Methotrexate; Sargramostim; Vincristine; Vinorelbine

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