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Sponsors and Collaborators: |
University of California, San Francisco Eisai Limited 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 |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00632827 |
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 | Intervention | Phase |
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Peripheral T-Cell Lymphoma |
Drug: REGIMEN Drug: REGIMEN B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 45 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment A: Experimental
Gemcitabine/Navelbine/Doxil Days 1 and 8 G-CSF Days 4-6 and 10-15
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Drug: REGIMEN
Induction chemotherapy
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Treatment B: Experimental
Cyclophosphamide/Doxorubicin/Vincristine on Day 1 Prednisone Days 1-5 Methotrexate Day 15
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Drug: REGIMEN B
Induction Chemotherapy
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologic diagnosis of any of the following:
Patients who test positive for HepBSAg or HepC Ab are eligible provided all of the following criteria are met:
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.
Exclusion Criteria:
Contact: Beth Davis, C.C.R.A. | 415.502.3176 | bdavis@medicine.ucsf.edu |
Contact: Natalie Jeha, M.A. | 415.476.4126 | njeha@medicine.ucsf.edu |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Beth Davis, C.C.R.A. 415-502-3176 bdavis@medicine.ucsf.edu | |
Contact: Natalie Jeha, M.A. 415.476.4126 njeha@medicine.ucsf.edu | |
Principal Investigator: Lawrence Kaplan, M.D. | |
Sub-Investigator: Charles Linker, M.D. | |
Sub-Investigator: Lloyd Damon, M.D. | |
Sub-Investigator: Jeffrey Wolf, M.D. | |
Sub-Investigator: Wei Ai, M.D. | |
Sub-Investigator: Karin Gaensler, M.D. | |
Sub-Investigator: Kristen Hege, M.D. | |
Sub-Investigator: Peter Sayre, M.D. | |
Sub-Investigator: Caroline Behler, M.D. | |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Justina First 314-362-4206 jfirst@dom.wustl.edu | |
Principal Investigator: Nancy Barlett, M.D. | |
United States, New York | |
Weill Cornell Medical College | Recruiting |
New York, New York, United States, 10021 | |
Contact: Sara Marcus 212-746-1493 sam2020@med.cornell.edu | |
Principal Investigator: Rebecca Elstrom, M.D. | |
United States, North Carolina | |
Wake Forest University Health Sciences | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Jennifer H. Black, BS, CCRP 336-806-7882 jhblack@wfubmc.edu | |
Principal Investigator: David Hurd, M.D. |
Responsible Party: | University of California San Francisco ( Lawrence Kaplan, M.D. and Charles Linker, M.D. ) |
Study ID Numbers: | UC-PTCL-ONTAK |
Study First Received: | February 28, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00632827 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Peripheral T-cell Lymphoma Immunoproliferative Disorders Denileukin diftitox Lymphoma, T-Cell |
Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Aggression Lymphoma, T-Cell, Peripheral Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Lymphoma, T-Cell, Peripheral Pharmacologic Actions Lymphatic Diseases |
Neoplasms Lymphoma, T-Cell Denileukin diftitox Therapeutic Uses Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |