NEWS HIGHLIGHTSMedia Articles Related to Ontak (Denileukin Diftitox)
FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.12]
The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.
Istodax Approved for Cutaneous T-Cell Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2009.11.09]
Title: Istodax Approved for Cutaneous T-Cell Lymphoma
Category: Health News
Created: 11/6/2009 4:10:00 PM
Last Editorial Review: 11/9/2009
FDA Approves Gloucester Pharmaceuticals' ISTODAX(R) For Patients With Cutaneous T-cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.06]
Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response.
Istodax Approved for Cutaneous T-Cell Lymphoma (HealthDay)
Source: Y! Health Lymphoma News [2009.11.06]
HealthDay - FRIDAY, Nov. 6 (HealthDay News) -- The Gloucester Pharmaceuticals
drug Istodax (romidepsin) has been approved by the U.S. Food and Drug
Administration to treat cutaneous T-cell lymphoma (CTCL) in people who
have tried at least one prior systemic therapy, the drug's manufacturer
said in a news release.
FDA Okays New Treatment for T-Cell Lymphoma
Source: MedPage Today Product Alert [2009.11.06]
WASHINGTON (MedPage Today) -- The FDA has approved romidepsin (Istodax) for patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy.
Published Studies Related to Ontak (Denileukin Diftitox)
Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network. [2009.07.16]
Acute graft-versus-host disease (aGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation...
Quality-of-life improvements in cutaneous T-cell lymphoma patients treated with denileukin diftitox (ONTAK). [2002.03]
Cutaneous T-cell lymphoma (CTCL) can be associated with painful, pruritic, disfiguring lesions. As part of a multicenter, randomized phase III trial in patients with heavily pretreated advanced and/or recurrent CTCL, the effects of an interleukin-2 receptor-targeted fusion protein, denileukin diftitox (DAB389IL-2, ONTAK), on patient-rated overall quality of life (QOL), skin appearance, and pruritus severity were evaluated...
Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. [2001.01.15]
PURPOSE: The objective of this phase III study was to determine the efficacy, safety, and pharmacokinetics of denileukin diftitox (DAB389IL-2, Ontak [Ligand Pharmaceuticals Inc, San Diego, CA]) in patients with stage Ib to IVa cutaneous T-cell lymphoma (CTCL) who have previously received other therapeutic interventions... CONCLUSION: Denileukin diftitox has been shown to be a useful and important agent in the treatment of patients whose CTCL is persistent or recurrent despite other therapeutic interventions.
Optimizing denileukin diftitox (Ontak) therapy. [2008.08]
Denileukin diftitox (Ontak) is a novel recombinant fusion protein consisting of peptide sequences for the enzymatically active and membrane translocation domain of diphtheria toxin linked to human IL-2.
De novo maintenance therapy with denileukin diftitox (Ontak) in a patient with peripheral T-cell lymphoma is associated with prolonged remission. [2008.07]
Peripheral T-cell lymphoma (PTCL) is an aggressive form of non-Hodgkin's lymphoma (NHL), associated with poor prognosis and without standard approach to treatment... This report documents the first case of de novo maintenance therapy with denileukin diftitox sustaining an ongoing complete response at the molecular level for 2 years in a patient with PTCL.
Clinical Trials Related to Ontak (Denileukin Diftitox)
Study of ONTAKŪ to Treat Cutaneous T-Cell Lymphoma (CTCL) [Completed]
The purpose of this research study is to evaluate how effective ONTAK is in the treatment of
cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein
called CD25 on the cancer cells makes a difference in how the body responds to the
treatment.
The hypothesis is that there is no difference in response rate for patients whose tumor cells
are CD25 positive or negative.
Ontak (Denileukin Diftitox) in Patients With SM [Completed]
Primary Objective:
1. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients.
Secondary Objectives:
1. To assess the safety of ONTAK in SM patients.
2. To evaluate the time to progression and duration of response following treatment with
ONTAK.
A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma [Active, not recruiting]
Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral
T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study
will also compare what kind of side effects these drugs cause and how often they occur. The
hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK
+ CHOP, will tolerate the treatment and will have a 20% improvement in response rate when
compared to CHOP alone.
A Study of ONTAK in Patients With Advanced Refractory Breast Cancer [Recruiting]
This is a phase I-II single arm (no placebo, no randomization) study in patients with advanced stage breast cancer whose disease has progressed or relapsed following standard therapy. Patients will receive intravenous ONTAK, an agent that we hypothesize may have anti-tumor activity in certain breast cancers, for 5 consecutive days every 21 days. A maximum of 6 cycles may be administered. Up to 20 patients will be accrued to this study.
Combination of Etanercept, Mycophenolate Mofetil (MMF), Denileukin Diftitox (Ontak), and Pentostatin With Steroids [Active, not recruiting]
Primary Objective:
1. To estimate the proportion of CR at Day 28 of therapy for newly diagnosed acute GVHD for
each of these agents given in combination with corticosteroids.
Secondary Objectives:
1. To determine:
1. proportion of partial response (PR), mixed response and progression at Day 28
2. proportion of treatment failure (no response, progression, or mortality) by Day 14
3. the incidence of GVHD flares requiring increasing therapy before Day 90.
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