Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma
Status:
Recruiting
Trial end date:
2027-01-01
Target enrollment:
Participant gender:
Summary
Background:
The disease follicular lymphoma (FL) develops when the body makes abnormal B-cells. These
cells usually build up in the lymph nodes, but can also affect other parts of the body.
Researchers want to see if a combination of drugs can attack the cancer cells in people with
FL.
Objective:
To see if copanlisib plus rituximab is effective at slowing the growth of FL.
Eligibility:
People with FL who have not had prior treatment for their disease
Design:
Participants will be screened with:
- Medical and cancer history
- Physical exam
- Review of symptoms and ability to perform daily activities
- Blood and urine tests
- Small amount of bone marrow removed by needle in the hip bone
- Scans of the chest, abdomen, and pelvis. Some scans will use a radioactive tracer.
Participants will get the study drugs in 28-day cycles for up to 13 cycles. Both are given as
an intravenous (IV) infusion. Copanlisib is given over about 1 hour. Rituximab is given over
several hours.
- For 1 cycle, they will get 3 weekly doses of copanlisib.
- For the next cycle, they will get 3 weekly doses of copanlisib and 4 weekly doses of
rituximab.
- For all other cycles, they will get 2-3 weekly doses of copanlisib and 1 dose of
rituximab.
Participants will repeat some screening tests during the cycles. They will give a cheek swab
and/or saliva sample and may have a tumor sample taken.
After treatment, some participants will have a few follow-up visits each year for 5 years,
then 1 each year. They will repeat screening tests.
Other participants will be contacted by phone every few months.