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NCT02301156 · ClinicalTrials.gov registry record · Phase 3
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
A Phase 3 study, sponsored by TG Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
NCT02301156: Completed Phase 3 study, sponsored by TG Therapeutics.
NCT02301156 is a Phase 3 study that has completed, run by TG Therapeutics. The registered enrollment target is 126 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02301156, a Phase 3 study, has completed, sponsored by TG Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
Study Summary
This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.
Primary Outcome
ORR: Percentage of participants with best overall response of partial response(PR) and complete response(CR). CR criteria: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters(cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolu
Interventions
- DRUG Ublituximab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2015-01-27 |
| Est. Completion | 2020-04-01 |
| Phase | Phase 3 |
What the finished NCT02301156 record still lists
NCT02301156 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Ublituximab is the first listed.
NCT02301156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02301156 about?
NCT02301156 is a clinical study titled "Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)". This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic L...
What is the current status of trial NCT02301156?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2015-01-27. Estimated completion is 2020-04-01.
What interventions are being tested in trial NCT02301156?
The interventions under investigation include: Ublituximab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02301156?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02301156's enrollment target sits among peer trials
126 1603rd of 2000 higher than 396 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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