The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)
Official Title
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients with Previously-Treated Chronic Lymphocytic Leukemia
Conditions
– Leukemia, Lymphocytic, Chronic
Study Type
Interventional
Study Design
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further Details
Study Start
Eligibility & Criteria
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV. Patients must have received at least one prior purine analogue-based chemotherapy regimen. ECOG Performance Status of 0, 1, or 2. Patients must not have had previous treatment with ONTAK. Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends. Patients must not receive therapy for CLL within 35 days prior to study.
Total Enrolment
Contact Details
[1] Peter MacCallum Cancer Institute, East Melbourne, Victoria, 3002, Australia[2] Ligand PharmaceuticalsAll content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.
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