This phase I trial studies the best dose of copanlisib when given together with combination
chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come
back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma
that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a
monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving copanlisib together with R-GCD
as second line therapy may improve the complete response rate for patients with diffuse large
B-cell lymphoma or follicular lymphoma.
OUTLINE: This is a dose-escalation study of copanlisib.
Patients receive copanlisib intravenously (IV) and gemcitabine IV on days 1 and 8,
carboplatin IV and rituximab IV on day 1, and dexamethasone orally (PO) or IV 30-60 minutes
prior to chemotherapy on day 1 or PO in the morning (AM) and 30-60 minutes prior to
chemotherapy on days 2-4. Patients also receive pegfilgrastim subcutaneously (SC) on day 8 or
9. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 1 year.
Grade 3b Follicular Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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