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NCT01647971 · ClinicalTrials.gov registry record · Phase 1
Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1 study of Non-Hodgkin's Lymphoma and Marginal Zone Lymphoma, sponsored by TG Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 8
- Study locations
NCT01647971: Completed Phase 1 study of Non-Hodgkin's Lymphoma and Marginal Zone Lymphoma, sponsored by TG Therapeutics.
NCT01647971 is a Phase 1 study of Non-Hodgkin's Lymphoma and Marginal Zone Lymphoma that has completed, run by TG Therapeutics. The registered enrollment target is 39 participants, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (82% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647971, a Phase 1 study of Non-Hodgkin's Lymphoma and Marginal Zone Lymphoma, has completed, sponsored by TG Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
Primary Outcome
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Conditions Studied
Interventions
- DRUG Ublituximab
Study Locations (8)
Georgia
- TG Therapeutics Investigational Trial Site - Athens
- TG Therapeutics Investigational Trial Site - Macon
Alabama
- TG Therapeutics Investigational Trial Site - Huntsville
Arkansas
- TG Therapeutics Investigational Trial Site - Jonesboro
Maryland
- TG Therapeutics Investigational Trial Site - Bethesda
New Jersey
- TG Therapeutics Investigational Trial Site - Morristown
New York
- TG Therapeutics Investigational Trial Site - New York
Tennessee
- TG Therapeutics Investigational Trial Site - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2012-07-19 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01647971 record still lists
NCT01647971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (82% lower).
The record links to 7 conditions, with Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Ublituximab is the first listed.
NCT01647971 lists 8 locations in 7 states (Georgia, Alabama, Arkansas).
Frequently Asked Questions
What is clinical trial NCT01647971 about?
NCT01647971 is a clinical study titled "Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma". The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
What is the current status of trial NCT01647971?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2012-07-19. Estimated completion is 2015-05.
What conditions does trial NCT01647971 study?
This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma, B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).
What interventions are being tested in trial NCT01647971?
The interventions under investigation include: Ublituximab (DRUG).
Who is sponsoring clinical trial NCT01647971?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01647971 being conducted?
This trial has 8 study locations across Alabama, Arkansas, Georgia, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01647971's enrollment target sits among peer trials
39 36th of 63 higher than 28 of 63 other Non-Hodgkin's Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin's 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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