Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)

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.

Conditions

• Peripheral T-Cell Lymphoma

Interventions

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

Sponsors & Collaborators

• Eisai Inc.

  collaborator INDUSTRY

• Washington University School of Medicine

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Lawrence Kaplan, MD · University of California, San Francisco

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-01

Primary Completion

2014-06-23

Completion

2016-06-23

FDA Drug

Yes

Countries

• United States

Study Locations