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 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of this trial is improvement in 3-year progression-free survival from 30% to 50% under the study regimen.
3 years
No
United States: Food and Drug Administration
UC-PTCL-ONTAK
NCT00632827
June 2008
June 2013
Name | Location |
---|---|
Washington University | St. Louis, Missouri 63110 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Weill Cornell Medical College | New York, New York 10021 |