NCT00632827

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 gemcitabine, vinorelbine, Doxil (GND) will be used followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose methotrexate (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 HiDAC/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.

Conditions

• Peripheral T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Chemotherapy medication used to treat a number of types of cancer
DRUG	Navelbine	Navelbine is an chemotherapy medication used to treat a number of types of cancer
DRUG	Doxorubicin Hydrochloride Liposome Injection	Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug
DRUG	Granulocyte-colony stimulating factor (G-CSF)	G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.
DRUG	Pegfilgrastim	Colony-stimulating factor 3 (CSF 3) and, is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. May be used instead of G-CSF
DRUG	Cyclophosphamide	Cancer medication that interferes with the growth and spread of cancer cells in the body
DRUG	Vincristine	Vincristine is a chemotherapy medication used to treat cancer. Vincristine works by stopping the cancer cells from separating into 2 new cells to stops the growth of the cancer
DRUG	Leucovorin	Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer.
DRUG	Methotrexate	Methotrexate is a chemotherapy medication used to treat cancer
DRUG	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer
DRUG	Cytarabine	Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma
DRUG	Etoposide	Etoposide is a is a chemotherapy medication used to treat cancer
DRUG	Carmustine	Carmustine is a chemotherapy medication used to treat cancer
DRUG	Denileukin diftitox	Denileukin diftitox is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. Denileukin diftitox could bind to Interleukin-2 receptors and introduce the diphtheria toxin into cells that express those receptors, killing the cells

Timeline

• Start date: 2008-07-01
• Primary completion: 2014-06-23
• Completion: 2016-06-23
• First posted: 2008-03-11
• Last updated: 2020-04-27
• Results posted: 2020-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study