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Denileukin diftitox

ONTAK (denileukin diftitox)

Myron Czuczman, MD

The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. The safety of treatment with ONTAK will also be studied. The hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to warrant further study.

A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's Lymphoma

A Phase II Multicenter Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non-Hodgkins Lymphoma.

Eisai Inc.

Skin and Connective Tissue Diseases

Leukemia

Mastocytosis

Mastocytosis, Systemic

Leukemia, Mast-Cell

Hematologic Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Systemic Mastocytosis

Analgesics

Interleukin-2

Analgesics, Non-Narcotic

Ontak administered intravenously on Days 1-5 at the dose of 9 µg/kg/day, with a rest period from Days 6-21.

9 µg/kg by vein Days 1-5 of a 21 day cycle.

Ontak (Denileukin Diftitox)

Srdan Verstovsek, MD

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.

Denileukin diftitox has been used for the treatment of a variety of disorders, in particular, malignant lymphoma, another blood-related disease. Denileukin diftitox is believed to be able to specifically attach to and kill malignant mast cells.

Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have blood (around 2 teaspoons) and bone marrow samples collected. To collect a bone marrow sample, an area of the hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. These samples will be used for tests to confirm the diagnosis of the disease. Women who are able to have children must have a negative blood pregnancy test.

If you are found to be eligible, you will receive denileukin diftitox as an injection by vein once a day for 5 days in a row. This will be repeated every 3 weeks (1 cycle). You will receive treatment on an outpatient basis. Treatment will continue as long as there is evidence that therapy is affecting the disease and is beneficial to you. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

During treatment you will have blood (around 1 teaspoon) collected twice during every 3-week period. You will also have bone marrow samples collected every 3 months during the treatment.

After the end of treatment, blood and bone marrow samples will be collected every 3 months until the disease gets worse or you start a different therapy. The blood and bone marrow samples will be used to look at response to therapy.

This is an investigational study. Denileukin diftitox has been approved by the FDA for the treatment of skin T-cell lymphoma and is commercially available. The use of denileukin diftitox in this study is investigational. You will be provided denileukin diftitox free of charge. Up to 25 participants will take part in this study. All be enrolled at M. D. Anderson.

Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)

ONTAK (Denileukin Diftitox) in Patients With Systemic Mastocytosis

Bone marrow samples used to look at response to therapy collected every 3 months until disease progression or different therapy started. Clinical efficacy assessed as objective response (major and partial response) for responding patients analyzed by the Kaplan-Meier method.

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's Lymphoma	NCT00211276	Lymphoma, B-Cel...	ONTAK (denileuk...	18 Years -	Eisai Inc.
Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)	NCT00493129	Leukemia Systemic Mastoc...	Ontak (Denileuk...	-	M.D. Anderson Cancer Center
Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)	NCT00493129	Leukemia Systemic Mastoc...	Ontak (Denileuk...	-	M.D. Anderson Cancer Center

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