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NCT03789240 · ClinicalTrials.gov registry record · Phase 2
Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma
A Phase 2 study of Follicular Lymphoma and Non-Hodgkin's Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT03789240 is a Phase 2 study of Follicular Lymphoma and Non-Hodgkin's Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants, below the 135-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03789240, a Phase 2 study of Follicular Lymphoma and Non-Hodgkin's Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Rituximab
- DRUG Copanlisib
- PROCEDURE Bone Marrow Aspiration/Biopsy
- DIAGNOSTIC_TEST CT Scans
- DIAGNOSTIC_TEST 18F-FDG-PET/CT Scan15
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03789240
The ClinicalTrials.gov registry entry for NCT03789240 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (76% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Follicular Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT03789240 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03789240 about?
NCT03789240 is a clinical study titled "Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma". 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: ...
What is the current status of trial NCT03789240?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2019-08-22. Estimated completion is 2027-01-01.
What conditions does trial NCT03789240 study?
This clinical trial studies the following conditions: Follicular Lymphoma, Non-Hodgkin's Lymphoma, NHL.
What interventions are being tested in trial NCT03789240?
The interventions under investigation include: Rituximab (BIOLOGICAL), Copanlisib (DRUG), Bone Marrow Aspiration/Biopsy (PROCEDURE), CT Scans (DIAGNOSTIC_TEST), 18F-FDG-PET/CT Scan15 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03789240?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03789240 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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