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NCT02612311 · ClinicalTrials.gov registry record · Phase 3
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
A Phase 3 study, sponsored by TG Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 603
- Enrollment target
NCT02612311: Clinical Trial Phase 3 study, sponsored by TG Therapeutics.
NCT02612311 is a Phase 3 study that was terminated before completion, run by TG Therapeutics. The registered enrollment target is 603 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02612311, a Phase 3 study, was terminated before completion, sponsored by TG Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 603 participants
- Enrollment target
Study Summary
This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.
Primary Outcome
PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes \>1.5 centimetres (cm) in the longest diameter (LD) and \>1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in
Interventions
- BIOLOGICAL Obinutuzumab
- BIOLOGICAL Ublituximab
- DRUG TGR-1202
- DRUG Chlorambucil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 603 participants |
| Start Date | 2015-11-19 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 3 |
Why NCT02612311 stopped before completion
NCT02612311 is an interventional study that assigns participants to a tested intervention. The registered 603 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 (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT02612311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02612311 about?
NCT02612311 is a clinical study titled "Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia". This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.
What is the current status of trial NCT02612311?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 603 participants. The study started on 2015-11-19. Estimated completion is 2023-02-22.
What interventions are being tested in trial NCT02612311?
The interventions under investigation include: Obinutuzumab (BIOLOGICAL), Ublituximab (BIOLOGICAL), TGR-1202 (DRUG), Chlorambucil (DRUG).
Who is sponsoring clinical trial NCT02612311?
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 NCT02612311's enrollment target sits among peer trials
603 607th of 2000 higher than 1,394 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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