Copanlisib Plus Ibrutinib in R/R CLL

Summary

Participation Requirements

Description

This is an open-label, phase II study, adding copanlisib to ibrutinib in select participants who are receiving ibrutinib for relapsed/refractory CLL. Copanlisib has not been approved by the U.S. Food and Drug Administration (FDA) for CLL, but it has been approved for use in relapsed/refractory folli...

This is an open-label, phase II study, adding copanlisib to ibrutinib in select participants who are receiving ibrutinib for relapsed/refractory CLL. Copanlisib has not been approved by the U.S. Food and Drug Administration (FDA) for CLL, but it has been approved for use in relapsed/refractory follicular lymphoma. Ibrutinib is approved by the FDA as a treatment option for CLL. This research study is: Trying to understand what effects, good or bad, treatment with copanlisib in combination with ibrutinib has in select participants who are receiving ibrutinib for relapsed/refractory CLL Determining if this approach is better or worse than the usual approach for this type of cancer Determining whether genomic changes in CLL cells and changes in immune response make treatment with the study drugs more or less effective The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive combination therapy for six months before resuming ibrutinib alone. They will continue therapy for as long as they do not have serious side effects and their disease does not get worse and will be followed for up to 5 years. It is expected that about 30 people will take part in this research study. Bayer HealthCare Pharmaceuticals is supporting this research study by providing the study drug, copanlisib. Ibrutinib will be obtained from commercial supply.

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