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

Exclusion Criteria

• •Less than 6 months from prior allogeneic stem cell transplant and/or patient with active graft versus host disease (GVHD) Grade \> or equal to 2.
• •Prior history of veno-occlusive disease of the liver.
• •Inability to comply with protocol requirements of this study for intravenous administration of ONTAK.
• •Pregnant women or lactating women who are breastfeeding or women planning to become pregnant during the treatment period.
• •Serious intercurrent medical illnesses or active infections that, in the investigators opinion, might interfere with the interpretation of the study safety data or compromise the patients ability to carry out the treatment program.
• •Known history of seropositivity for HIV or chronic hepatitis (testing for HIV is not required).
• •Known hypersensitivity to ONTAK or any of its components: diptheria toxin, interleukin-2 or excipients.
• •Experimental therapy within 4 weeks prior to study entry.
• •Patients diagnosed with congestive heart failure, NYHA Class III or IV, ventricular tachycardia, fibrillation, or a history of myocardial infarction in the 12 months prior to study entry.
• •Any prior radiation therapy within four weeks of enrollment, or prior radiation therapy to the only site of evaluable disease unless disease progression has occurred in that site.
• •Patients on concurrent corticosteroids as treatment for NHL. The use of tapering doses or low doses of corticosteroids for resolving GVHD, or the use of corticosteroids as premedication prior to ONTAK or as a transient treatment for hypersensitivity reactions is permitted as necessary.
• •History of prior malignancy within the preceding 5 years, except for successfully treated cervical carcinoma in situ or basal cell carcinoma.