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NCT04323956 · ClinicalTrials.gov registry record · Phase 1
Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and Ann Arbor Stage II Follicular Lymphoma, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT04323956 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Ann Arbor Stage II Follicular Lymphoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 50 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (77% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04323956, a Phase 1 study of Diffuse Large B Cell Lymphoma and Ann Arbor Stage II Follicular Lymphoma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I/Ib trial studies the side effects and best dose of parsaclisib with or without polatuzumab-vedotin (Pola) plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone \[PaR-CHOP\]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer 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. Polatuzumab-vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as anti-CD79b receptors, and delivers vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- BIOLOGICAL Pegfilgrastim
- DRUG Polatuzumab Vedotin
- DRUG Parsaclisib
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2028-05-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04323956
The ClinicalTrials.gov registry entry for NCT04323956 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (77% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04323956 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04323956 about?
NCT04323956 is a clinical study titled "Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma". This phase I/Ib trial studies the side effects and best dose of parsaclisib with or without polatuzumab-vedotin (Pola) plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone \[PaR-CHOP\]) and to see how well they work compared with...
What is the current status of trial NCT04323956?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2020-06-15. Estimated completion is 2028-05-16.
What conditions does trial NCT04323956 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Ann Arbor Stage II Follicular Lymphoma, Ann Arbor Stage III Follicular Lymphoma, Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma.
What interventions are being tested in trial NCT04323956?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Pegfilgrastim (BIOLOGICAL), Polatuzumab Vedotin (DRUG), Parsaclisib (DRUG).
Who is sponsoring clinical trial NCT04323956?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04323956 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.