33 Participants Needed

Copanlisib + Rituximab for Follicular Lymphoma

NM
MJ
Overseen ByMark J Roschewski, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Rituximab, used in treating follicular lymphoma, has been generally safe but may increase the risk of infections, including hepatitis B reactivation and a rare brain infection called PML. It's important to screen for hepatitis B and consider preventive antiviral treatment.12345

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

MJ

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

My organ functions are within normal ranges according to recent tests.
I can take care of myself and am up and about more than half of the day.
I have FL and haven't had chemo, targeted therapy, or antibody treatment before copanlisib, but may have had radiation over 12 weeks ago.
See 7 more

Exclusion Criteria

My lymphoma has spread to my brain or spinal cord.
My diabetes is not under control despite taking my medication.
I have not had a stroke or mini-stroke in the last 3 months.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Window Treatment

Participants receive copanlisib monotherapy for a single 28-day cycle

4 weeks
3 visits (in-person)

Induction Therapy

Participants receive copanlisib and rituximab for up to 6 cycles

24 weeks
Weekly visits during the first cycle, then monthly

Extended Induction Therapy

Participants with partial response receive an additional 6 cycles of copanlisib and rituximab

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Annual visits, with additional visits every few months for some participants

Treatment Details

Interventions

  • Copanlisib
  • Rituximab
Trial Overview The study tests the effectiveness of copanlisib plus rituximab in slowing FL growth. It involves up to 13 cycles of treatment over 28 days each, with both drugs administered through IV infusions at varying intervals.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment2 Interventions
Window of treatment with Copanlisib 60mg via IV for a single 28 day cycle, once weekly for the first 3 weeks and then a 1 week break followed by induction therapy with copanlisib and rituximab. Induction therapy will be 6 cycles (28 days) of: copanlisib dose and administration same as window, rituximab 375mg/m2 via IV, once weekly for the first 4 weeks during cycle 1, subsequent cycles (cycles 2-6), rituximab will be dosed only once on day 1 of the cycle.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a review of 49,927 reports from the Spanish Pharmacovigilance System, rituximab was associated with common adverse reactions such as white cell disorders, hypotension, dyspnoea, and pneumonitis, with white cell disorders typically developing around 21 days after treatment.
Trastuzumab was primarily linked to cardiac failure, with many cases occurring alongside other medications, reinforcing the known safety profiles of both drugs as consistent with findings from large clinical trials.
Post-marketing safety of antineoplasic monoclonal antibodies: rituximab and trastuzumab.González, V., Salgueiro, E., Jimeno, FJ., et al.[2015]
In a study of 40 patients with low-grade or follicular B-cell non-Hodgkin's lymphoma, the combination of Rituxan (Rituximab) and CHOP chemotherapy resulted in a high overall response rate of 95%, with 55% achieving complete remission.
The combination therapy showed promising safety, with common side effects being manageable, and it also indicated potential for clearing minimal residual disease, as evidenced by the conversion of the bcl-2 translocation from positive to negative in several patients.
Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy.Czuczman, MS., Grillo-López, AJ., White, CA., et al.[2022]
Rituximab has been shown to be very safe over more than 10 years of use, but it can significantly increase the risk of infections, especially in patients with low-grade lymphoma or severe immunodeficiency, such as those with HIV or on immunosuppressive therapies.
The most critical infection associated with rituximab is hepatitis B reactivation, which can lead to severe liver failure; therefore, screening for hepatitis B and considering preemptive antiviral treatment is essential for patient safety.
Rituximab-associated infections.Gea-Banacloche, JC.[2020]

References

Post-marketing safety of antineoplasic monoclonal antibodies: rituximab and trastuzumab. [2015]
Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. [2022]
Rituximab-associated infections. [2020]
Critical appraisal of rituximab in the maintenance treatment of advanced follicular lymphoma. [2022]
Rescue Therapy Using Rituximab for Multiple Sclerosis. [2017]
Update on front-line therapy for follicular lymphoma: chemo-immunotherapy with rituximab and survival. [2015]
Rituximab therapy in malignant lymphoma. [2022]
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. [2021]
Biological therapy doublets: pairing rituximab with interferon, lenalidomide, and other biological agents in patients with follicular lymphoma. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Optimization of postremission therapy in follicular lymphoma: efficacy of rituximab maintenance. [2019]
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