This study will investigate the effects of ibrutinib (Imbruvica) in patients with non-responsive leukemia/lymphoma after a stem-cell transplant. The main outcome that will be measured is the time after treatment before patients experience cancer worsening. This trial is recruiting in the United States.
The details
Some patients with leukemia/lymphoma lose response over time (relapsed). Others do not respond at all (refractory). Stem cell transplant is often used to treat these patients. This involves the transfer of cells to the patient. Ibrutinib is a new therapy which may be effective for non-responsive leukemia/lymphoma. It is important to investigate the effects of different combinations of treatments for non-responsive lymphoma.
This study will evaluate the effects of ibrutinib in patients with non-responsive leukemia/lymphoma who have received a stem-cell transplant. The duration of time before a patient experiences cancer worsening in the 12 months after treatment will be the main outcome measured.
Who are they looking for?
75 patients with non-responsive leukemia/lymphoma will be included. Participants must be receiving their first stem-cell transplant for chronic lymphocytic leukemia (CLL), Hodgkin Lymphoma (HL), or Mantle cell lymphoma (MCL) or follicular center cell lymphoma (FL). Patients in group 1 must have CLL or MCL. Those with CLL must be non-responsive after at least 2 different therapies. Those with MCL must be non-responsive after at least 1 therapy. Patients in group 2 must have follicular lymphoma or Hodgkin disease. Those with follicular lymphoma or Hodgkin disease must be non-responsive after at least 2 different treatments. Participants may not be pregnant or breastfeeding during this study.
Those who have experienced cancer worsening before undergoing stem cell transplant cannot participate. Those who are using anticoagulants or have another type of cancer cannot participate. Those who have already undergone stem-cell transplant or who are planning to donate cells for stem cell transplant in the 3 months after taking part cannot be included. Patients who have had a stroke or brain bleed within 6 months of taking part cannot be enrolled.
How will it work
Between 60 and 90 days after a stem cell transplant, participants will receive ibrutinib orally once a day for up to one year unless participants experience cancer worsening or unacceptable side effects. As such, cancer worsening and treatment-related side-effects will be measured.
