Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- 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 ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment A
Gemcitabine/Navelbine/Doxil Days 1 and 8 G-CSF Days 4-6 and 10-15
Experimental: Treatment B
Cyclophosphamide/Doxorubicin/Vincristine on Day 1 Prednisone Days 1-5 Methotrexate Day 15
Drug: REGIMEN B
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632827
|United States, Missouri|
|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|