Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03113422 · ClinicalTrials.gov registry record · Phase 2
Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy
A Phase 2 study, sponsored by PrECOG.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT03113422 is a Phase 2 study that has completed, run by PrECOG. The registered enrollment target is 56 participants.
The verdict
NCT03113422, a Phase 2 study, has completed, sponsored by PrECOG.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma. As of 9/5/2018, a higher than expected incidence of tumor lysis syndrome (TLS) was experienced among patients receiving venetoclax, obinutuzumab and bendamustine on Cycle 1, Day 1 of treatment. TLS is caused by the fast breakdown of cancer cells. These patients developed an increase in some of their blood tests (uric acid, phosphorus, potassium and/or creatinine). They received a medication called rasburicase and continued with treatment. It is unclear if the TLS was due to the venetoclax or the standard treatment of obinutuzumab and bendamustine. For the remaining patients, venetoclax will start on Cycle 2, Day 1 (previously Cycle 1, Day 1). As of 9/16/2021, additional maintenance therapy has been suspended for those patients who remain on study. These patients will not receive any further treatment and will move on to the two year survival follow-up.
Interventions
- DRUG Induction Venetoclax
- DRUG Maintenance Venetoclax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-12-27 |
| Est. Completion | 2023-01-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03113422
The ClinicalTrials.gov registry entry for NCT03113422 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PrECOG, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Induction Venetoclax is the first listed.
NCT03113422 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03113422 about?
NCT03113422 is a clinical study titled "Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy". Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell g...
What is the current status of trial NCT03113422?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2017-12-27. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT03113422?
The interventions under investigation include: Induction Venetoclax (DRUG), Maintenance Venetoclax (DRUG).
Who is sponsoring clinical trial NCT03113422?
This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.