Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Esai Pharmaceuticals

Washington University School of Medicine

Wake Forest University

University of Chicago

University of North Carolina

Roswell Park Cancer Institute

Weill Medical College of Cornell University

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00632827

First received: February 28, 2008

Last updated: April 11, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 28, 2008
Last Updated Date	April 11, 2012
Start Date ^ICMJE	June 2008
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 10, 2008)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00632827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak)
Official Title ^ICMJE	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
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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Peripheral T-Cell Lymphoma
Intervention ^ICMJE	Drug: REGIMEN Induction chemotherapy Drug: REGIMEN B Induction Chemotherapy
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	45
Estimated Completion Date	June 2013
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00632827
Other Study ID Numbers ^ICMJE	UC-PTCL-ONTAK
Has Data Monitoring Committee	Yes
Responsible Party	University of California, San Francisco
Study Sponsor ^ICMJE	University of California, San Francisco
Collaborators ^ICMJE	Esai Pharmaceuticals Washington University School of Medicine Wake Forest University University of Chicago University of North Carolina Roswell Park Cancer Institute Weill Medical College of Cornell University
Investigators ^ICMJE	Not Provided
Information Provided By	University of California, San Francisco
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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