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

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ClinicalTrials.gov 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
Information provided by (Responsible Party):

February 28, 2008
March 11, 2008
October 6, 2014
June 2008
December 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00632827 on ClinicalTrials.gov Archive Site
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Not Provided
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Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)
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
This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.

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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peripheral T-Cell Lymphoma
  • Drug: REGIMEN
    Induction chemotherapy
  • Drug: REGIMEN B
    Induction Chemotherapy
  • Experimental: Treatment A
    Gemcitabine/Navelbine/Doxil Days 1 and 8 G-CSF Days 4-6 and 10-15
    Intervention: Drug: REGIMEN
  • Experimental: Treatment B
    Cyclophosphamide/Doxorubicin/Vincristine on Day 1 Prednisone Days 1-5 Methotrexate Day 15
    Intervention: Drug: REGIMEN B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Lawrence Kaplan, University of California, San Francisco
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
Not Provided
University of California, San Francisco
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP