NCT04685915

Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL

A Phase II Study of Copanlisib to Deepen Response in CLL Patients on Ibrutinib or Acalabrutinib in the Relapsed/Refractory Setting

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Inhye Ahn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is examining the effect of adding a fixed duration of copanlisib to ibrutinib or acalabrutinib in select participants who have been on ibrutinib or acalabrutinib for at least six months for relapsed/refractory chronic lymphocytic leukemia (CLL). The names of the study drugs involved in this study are: * Copanlisib * Ibrutinib * Acalabrutinib

Detailed description

This is an open-label, phase II study, adding copanlisib to ibrutinib or acalabrutinib 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 and acalabrutinib are 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 or acalabrutinib 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 and acalabrutinib will be obtained from commercial supply.

Conditions

• Chronic Lymphocytic Leukemia (CLL)

Interventions

Type	Name	Description
DRUG	Ibrutinib	Capsule, taken by mouth once daily
DRUG	Copanlisib	Intravenous Infusion
DRUG	Acalabrutinib	Capsule, taken by mouth twice daily

Timeline

• Start date: 2021-02-18
• Primary completion: 2023-03-01
• Completion: 2028-03-01
• First posted: 2020-12-28
• Last updated: 2025-05-22

Regulatory

• FDA-regulated drug study