Study on Copanlisib and Rituximab for Untreated Follicular Lymphoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03789240
This clinical trial is exploring whether a combination of the drugs copanlisib and rituximab can effectively slow down the growth of follicular lymphoma in patients who have not received prior treatment for their condition.
Patient Parameters
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Program Overview
Follicular lymphoma is a type of cancer that occurs when abnormal B-cells build up in the lymph nodes and other parts of the body. This study aims to find out if using two drugs, copanlisib and rituximab, can help slow down the growth of this cancer. Participants will receive these drugs in cycles over several months, and their health will be closely monitored through various tests and follow-up visits.
Description
Follicular lymphoma (FL) is a common type of slow-growing non-Hodgkin's lymphoma. While current treatments can lead to long-lasting remissions, they are not usually curative. This study is testing a new approach using copanlisib, a drug that targets specific pathways in cancer cells, and rituximab, an antibody therapy, to see if they can provide deep and lasting remissions without the need for traditional chemotherapy.
Participants will receive the study drugs in 28-day cycles for up to 13 cycles. Copanlisib is given as an IV infusion over about an hour, while rituximab is given over several hours. The treatment plan includes different combinations of these drugs over the cycles. Participants will undergo regular tests, including blood and urine tests, scans, and possibly a tumor sample collection, to monitor their response to the treatment.
After completing the treatment, some participants will have follow-up visits for up to five years, while others will be contacted by phone to check on their health status. The study aims to determine the effectiveness of this drug combination in achieving complete remission in patients with untreated follicular lymphoma.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of follicular lymphoma, grade 1-2 or 3a.
- Disease must be at stage II-IV, or stage I if previously treated with radiation and relapsed.
- No prior systemic treatment for follicular lymphoma, except for radiation therapy completed more than 12 weeks before starting the study.
- Must meet criteria for starting systemic therapy, such as having symptoms or significant disease progression.
- Must provide a tumor sample for study purposes.
- Must be 18 years or older.
- Must have good overall health and organ function as indicated by specific blood tests.
- Women of childbearing potential and men must agree to use effective contraception during and after the study.
Exclusion Criteria
- Known involvement of the central nervous system by lymphoma.
- History of immunodeficiency or active infections like hepatitis B or C.
- Uncontrolled health conditions such as heart failure, recent heart attack, or severe diabetes.
- Pregnant or breastfeeding women.
- Recent major surgery or injury.
- Any other condition that could interfere with the study or increase risk to the patient.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
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