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NCT03462719 · ClinicalTrials.gov registry record · Phase 3
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
A Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
- 20
- Study locations
NCT03462719: Active Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Research & Development.
NCT03462719 is a Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 211 participants, below the 472-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03462719, a Phase 3 study of Leukemia, Lymphocytic, Chronic, B-Cell, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).
Primary Outcome
PFS: time between date of randomization and date of disease progression, as assessed by IRC, or date of death due to any cause, whichever occurs first, regardless of use of subsequent anti-cancer therapy prior to PD or death using iWCLL2008 criteria : New enlarged lymph nodes \>15 mm, new hepatomegaly or splenomegaly, or other organ infiltrates, bone lesion, ascites or pleural effusion due to CLL; \>=50% increase in longest diameter (LDi) from nadir in existing lymph node (LDi \>15 mm) or \>=50%
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Ibrutinib
- DRUG Chlorambucil
- DRUG Ibrutinib (as Subsequent Therapy)
Study Locations (20)
Other
- Institut - Jules Bordet - Anderlecht
- ZNA Stuivenberg - Antwerp
- Universitair Ziekenhuis Gent - Ghent
- Virga Jessa Ziekenhuis - Hasselt
- UZ Leuven Gasthuisberg - Leuven
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika - Brno
- Fakultni nemocnice Hradec Kralove - Hradec Králové
- Fakultni Nemocnice Ostrava - Ostrava
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni - Pilsen
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie - Prague
- Aalborg University Hospital - Aalborg
Alberta
- Arthur J E Child Comprehensive Cancer Centre - Calgary
- Cross Cancer Institute - Edmonton
Ontario
- Juravinski Cancer Centre - Hamilton
- The Ottawa Hospital - General Campus - Ottawa
Quebec
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont - Montreal
- Jewish General Hospital - Montreal
Kentucky
- Norton Cancer Institute - Louisville
New Jersey
- John Theurer Cancer Center - Hackensack
North Carolina
- Novant Health - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2029-04-05 |
| Phase | Phase 3 |
What the registry record for NCT03462719 still lists
NCT03462719 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 472-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Leukemia, Lymphocytic, Chronic, B-Cell appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT03462719 names 20 study sites across 7 states, led by Other, Alberta, Ontario.
Frequently Asked Questions
What is clinical trial NCT03462719 about?
NCT03462719 is a clinical study titled "A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).
What is the current status of trial NCT03462719?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2018-04-17. Estimated completion is 2029-04-05.
What conditions does trial NCT03462719 study?
This clinical trial studies the following conditions: Leukemia, Lymphocytic, Chronic, B-Cell.
What interventions are being tested in trial NCT03462719?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Ibrutinib (DRUG), Chlorambucil (DRUG), Ibrutinib (as Subsequent Therapy) (DRUG).
Who is sponsoring clinical trial NCT03462719?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03462719 being conducted?
This trial has 20 study locations across Kentucky, New Jersey, North Carolina, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03462719's enrollment target sits among peer trials
211 6th of 11 higher than 6 of 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia, Lymphocytic, Chronic, B-Cell 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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