This phase 2 clinical trial will test the safety and effectiveness of an ibrutinib (Imbruvica) and fludarabine (Fludara) treatment in patients with previously untreated chronic lymphocytic leukemia (CLL). The primary outcome will be measured by the safety and effectiveness of the treatment.
The details
Ibrutinibis a drug that stops the growth of B-cells and may decrease the spread of CLL. It binds to the Bruton's tyrosine kinase (BTK), a protein essential for B-cell growth and development. Since cancerous lymphocytes rely on B-cell signals to develop, blocking BTKs could stop the spread of cancer. Fludarabine is a chemotherapy often used to treat chronic lymphocytic leukemia. It works by inhibiting (blocking) DNA synthesis or repair in blood cells, eventually leading to cell death. It is unclear whether the two treatments combined will effectively treat CLL.
This trial will measure the effectiveness of ibrutinib and fludarabine. The outcomes to be measured are they safety and effectiveness over 2 years.
Who are they looking for?
This trial is recruiting 32 patients with CLL (or small lyphocytic lymphoma) who have not yet started treatment. Participants must have adequate organ function. Ideal candidates should not have had a stroke or intracranial hemorrhage within 6 months prior to entry or undergone surgery within 4 weeks of enrollment. Patients with a history of prior malignancies should be disease free for 2 years. Patients should not have any type of bleeding disorder.
How will it work
Patients will take ibrutinib daily by mouth throughout a 28-day cycle. Fludarabine will be given intravenously (through IV into a vein) on the first 5 days of cycle 3 and 4. Participants can also expect to undergo CT and PET scans and bone marrow biopsies during the study.
