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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00632827
Recruitment Status : Unknown
Verified October 2014 by Lawrence Kaplan, University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2008
Last Update Posted : October 6, 2014
Eisai Inc.
Washington University Early Recognition Center
Wake Forest University Health Sciences
University of Chicago
University of North Carolina
Roswell Park Cancer Institute
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Lawrence Kaplan, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral T-Cell Lymphoma Drug: REGIMEN Drug: REGIMEN B Phase 2

Detailed Description:

This protocol proposes first to increase the proportion of patients who achieve adequate initial disease control and are able to proceed to autologous stem cell transplant (ASCT) in first complete or partial remission. It administers intensive and novel induction therapy.

Two cycles of GND (gemcitabine, vinorelbine, Doxil) will be used followed by two cycles of augmented dose CHOP (Cyclophosphamide) plus high-dose MTX. Patients will be restaged after two cycles of GND to assess response to GND alone and again after the second cycle of augmented CHOP/high-dose MTX.

Those achieving a remission status will receive intensive consolidation with HDAC/etoposide followed by stem cell mobilization. A five-day course of denileukin diftitox (Ontak) will be administered at and will serve as an in vivo purge. This will be followed by autologous stem cell transplant.

Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen will go on to consolidation/mobilization and autologous stem cell transplant.

Post-transplant, denileukin diftitox will also be used as an additional module of therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak) for In-vivo Purging and Post-Transplant Therapy: A Multicenter Phase II Clinical Trial
Study Start Date : June 2008
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Treatment A
Gemcitabine/Navelbine/Doxil Days 1 and 8 G-CSF Days 4-6 and 10-15
Induction chemotherapy

Experimental: Treatment B
Cyclophosphamide/Doxorubicin/Vincristine on Day 1 Prednisone Days 1-5 Methotrexate Day 15
Induction Chemotherapy

Primary Outcome Measures :
  1. The primary endpoint of this trial is improvement in 3-year progression-free survival from 30% to 50% under the study regimen. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic diagnosis of any of the following:

    • Peripheral T-cell lymphoma not otherwise specified (PTCL-U),(IPI >2)
    • Angioimmunoblastic T-cell lymphoma (IPI >2)
    • Non-primary cutaneous Alk-1-negative anaplastic large cell lymphoma
    • Extranodal NK/T lymphoma (Excluding stage I/II nasal disease)
    • Blastic NK cell lymphoma
    • Enteropathy type T-cell lymphoma
    • Subcutaneous 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, AST < 3x upper limit of normal
  • Patients who test positive for HepBSAg or HepC Ab are eligible provided all of the following criteria are met:

    • bilirubin ≤ 2 x upper limit of normal;
    • 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 amivudine (3TC) or investigator's preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter.

  • Neutrophils >1000/uL platelets > 100,000/uL
  • Albumin > 3.0 mg/dL
  • HIV-negative
  • 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 in 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00632827

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United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
University of California, San Francisco
Eisai Inc.
Washington University Early Recognition Center
Wake Forest University Health Sciences
University of Chicago
University of North Carolina
Roswell Park Cancer Institute
Weill Medical College of Cornell University

Additional Information:
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Responsible Party: Lawrence Kaplan, Clinical Professor of Medicine; Director, Adult Lymphoma Program, University of California, San Francisco Identifier: NCT00632827     History of Changes
Other Study ID Numbers: UC-PTCL-ONTAK
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Denileukin diftitox
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs