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

Stopped early · Phase 2

Conditions studied: Peripheral T-Cell Lymphoma

In brief

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

Key facts

Study ID

NCT00632827

Run by

University of California, San Francisco

People needed

21

Starts

2008-07-01

Expected to finish

2016-06-23

Last updated by the study team

2020-04-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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