Early Access Program for Ibrutinib in Patients with Relapsed or Hard-to-Treat Chronic Lymphocytic Leukemia (CLL)
Sponsor: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials ID:NCT02437019
This study offers early access to the medication Ibrutinib for patients with Chronic Lymphocytic Leukemia (CLL) that has returned or is difficult to treat. The study also gathers safety information about the drug while it is not yet available on the market.
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Program Overview
The aim of this program is to provide patients with CLL, whose disease has come back or is hard to treat, early access to Ibrutinib. This study will also collect safety data on the drug. Participants will take Ibrutinib daily in a 28-day cycle until their disease worsens, they experience unacceptable side effects, or they no longer benefit from the treatment. The study will monitor participants' health and safety throughout the program. Participants will continue to receive Ibrutinib until it is approved for marketing or for six months after approval.
Description
This study is open-label, meaning everyone knows what treatment is being given, and involves multiple medical centers. It has two phases: a Screening Phase, which happens about 30 days before starting the treatment, and a Program Drug Phase, which lasts from the first day of treatment until 30 days after the last dose. Participants will take 420 mg of Ibrutinib by mouth once a day in a 28-day cycle. The treatment will continue without breaks until the disease progresses, side effects become too severe, or the treatment is no longer beneficial. Participants will be monitored for safety throughout the study. They will continue to receive Ibrutinib through this program until it is approved for sale or for six months after approval.
Eligibility Criteria
Inclusion Criteria
- Have a performance status score of less than 2, meaning they are fully active or restricted in physically strenuous activity but ambulatory.
- Diagnosed with Chronic Lymphocytic Leukemia (CLL) that meets specific criteria, including having certain markers on their B-cells and a high B-lymphocyte count.
- Have active disease that meets at least one of the criteria set by the International Workshop on CLL.
- Have received at least one previous treatment for CLL and are not suitable for certain other treatments.
- Able to receive all treatment and monitoring as an outpatient at the study center.
Exclusion Criteria
- Have cancer in the central nervous system or a type of leukemia called prolymphocytic leukemia.
- Have a history of or currently suspected to have Richter's transformation.
- Have uncontrolled autoimmune conditions affecting blood cells, like autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
- Have previously taken Ibrutinib or participated in an Ibrutinib study.
- Need treatment with certain strong medications that affect how the body processes drugs.
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