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NCT03223610 · ClinicalTrials.gov registry record · Phase 1
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) 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
- 155
- Enrollment target
- 1
- Study location
NCT03223610: Recruiting Phase 1 study of Lymphoma and Diffuse Large B Cell Lymphoma, sponsored by National Cancer Institute (NCI).
NCT03223610 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 155 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03223610, 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
- 155 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR). Objective: To study the safety of ViPOR for people with B-cell lymphoma. Eligibility: People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Tissue sample from previous procedure * Imaging scans * Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days. Participants will have a bone marrow aspiration before treatment. Participants may have tumor samples taken. Participants will get ViPOR in 21-day cycles. For up to 6 cycles: * Participants will get one drug by IV on days 1 and 2. * Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring. Participants will keep a drug diary. Participants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles. Participants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.
Primary Outcome
Number and grade of adverse events
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Prednisone
- BIOLOGICAL Obinutuzumab
- DRUG Ibrutinib
- DRUG Revlimid (lenalidomide)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What NCT03223610 shows while recruiting
NCT03223610 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (68% lower).
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT03223610 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03223610 about?
NCT03223610 is a clinical study titled "Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma". Background: B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and le...
What is the current status of trial NCT03223610?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2018-02-09. Estimated completion is 2027-12-01.
What conditions does trial NCT03223610 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 NCT03223610?
The interventions under investigation include: Venetoclax (DRUG), Prednisone (DRUG), Obinutuzumab (BIOLOGICAL), Ibrutinib (DRUG), Revlimid (lenalidomide) (DRUG).
Who is sponsoring clinical trial NCT03223610?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03223610 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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Where NCT03223610's enrollment target sits among peer trials
155 58th of 299 higher than 242 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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