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NCT04739813 · ClinicalTrials.gov registry record · Phase 1
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
A Phase 1 study of Lymphoma and Diffuse Large B Cell Lymphoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT04739813: Recruiting Phase 1 study of Lymphoma and Diffuse Large B Cell Lymphoma, sponsored by National Cancer Institute (NCI).
NCT04739813 is a Phase 1 study of Lymphoma and Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04739813, a Phase 1 study of Lymphoma and Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Aggressive B-cell lymphomas can be cured but people with disease that resists treatment or that returns after treatment have poor outcomes with standard therapies. Indolent B-cell lymphomas are generally incurable with standard therapy and treatment is aimed at controlling symptoms and achieving a durable remissions. Researchers want to see if a combination of drugs can help patients with both aggressive and indolent B-cell lymphomas. Objective: To learn if it is safe and effective to give polatuzumab along with venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide to people with certain B-cell lymphomas. Eligibility: Adults ages 18 and older with relapsed and/or refractory B-cell lymphoma who have had at least one prior cancer treatment. Design: Participants will be screened with: Medical history Physical exam Assessment of how they do their daily activities Blood and urine tests Heart function test Tissue biopsy (if needed) Body imaging scans (may get a contrast agent through an intravenous (IV) catheter) Participants will have a bone marrow aspiration and/or biopsy. A needle will be put into the hipbone. Bone marrow will be removed. Participants may give blood, tissue, saliva, or cheek swab samples. They may have optional biopsies. Screening tests will be repeated during the study. Treatment will be given for up to 6 cycles. Each cycle lasts 21 days. Participants will take venetoclax and prednisone tablets by mouth. They will take ibrutinib and lenalidomide capsules by mouth. They will get obinutuzumab and polatuzumab by IV infusion. They will keep a medicine diary. Participants will visit the clinic 30 days after treatment ends. They will have follow-up visits for 5 years. If needed, they can visit their local doctor instead. They may be contacted by phone, mail, etc., for the rest of their life....
Primary Outcome
Number and grade of adverse events
Conditions Studied
Interventions
- DRUG prednisone
- DRUG ibrutinib
- BIOLOGICAL obinutuzumab
- DRUG Revlimid
- BIOLOGICAL Polatuzumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2031-04-04 |
| Phase | Phase 1 |
What NCT04739813 shows while recruiting
NCT04739813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (89% lower).
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which prednisone is the first listed.
NCT04739813 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04739813 about?
NCT04739813 is a clinical study titled "Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma". Background: Aggressive B-cell lymphomas can be cured but people with disease that resists treatment or that returns after treatment have poor outcomes with standard therapies. Indolent B-cell lymphomas are generally incurable with standard therapy and treatment is aimed at controlling symptoms and ...
What is the current status of trial NCT04739813?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-07-09. Estimated completion is 2031-04-04.
What conditions does trial NCT04739813 study?
This clinical trial studies the following conditions: Lymphoma, Diffuse Large B Cell Lymphoma, Non-Hodgkin Lymphoma, Burkitt Lymphoma.
What interventions are being tested in trial NCT04739813?
The interventions under investigation include: prednisone (DRUG), ibrutinib (DRUG), obinutuzumab (BIOLOGICAL), Revlimid (DRUG), Polatuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04739813?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04739813 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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