Copanlisib + Rituximab for Follicular Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you cannot continue on any medications that are excluded, so it's best to discuss your current medications with the trial team.
Is the combination of Copanlisib and Rituximab safe for treating follicular lymphoma?
How is the drug combination of Copanlisib and Rituximab unique for treating follicular lymphoma?
The combination of Copanlisib and Rituximab is unique because it pairs a PI3K inhibitor (Copanlisib) with a monoclonal antibody (Rituximab), potentially offering a novel mechanism of action by targeting different pathways in follicular lymphoma, which may enhance treatment efficacy compared to traditional chemotherapy regimens.678910
What is the purpose of this trial?
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 diseaseDesign: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.
Research Team
Mark J Roschewski, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
This trial is for people with untreated Follicular Lymphoma (FL) who need systemic therapy due to symptoms or disease progression. Participants must be at least 8 years old, have good organ function, and not have had previous FL treatments except radiation. They should also agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Window Treatment
Participants receive copanlisib monotherapy for a single 28-day cycle
Induction Therapy
Participants receive copanlisib and rituximab for up to 6 cycles
Extended Induction Therapy
Participants with partial response receive an additional 6 cycles of copanlisib and rituximab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Copanlisib
- Rituximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor