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NCT03364231 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
A Phase 2 study of Marginal Zone Lymphoma and Waldenstrom Macroglobulinemia, sponsored by TG Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 4
- Study locations
NCT03364231: Completed Phase 2 study of Marginal Zone Lymphoma and Waldenstrom Macroglobulinemia, sponsored by TG Therapeutics.
NCT03364231 is a Phase 2 study of Marginal Zone Lymphoma and Waldenstrom Macroglobulinemia that has completed, run by TG Therapeutics. The registered enrollment target is 21 participants, below the 102-participant average among 49 other Marginal Zone Lymphoma trials with a reported enrollment target (79% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03364231, a Phase 2 study of Marginal Zone Lymphoma and Waldenstrom Macroglobulinemia, has completed, sponsored by TG Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 4
- Study locations
Study Summary
This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded to standard treatment.
Primary Outcome
ORR for MZL=percentage of participants with complete response (CR)/partial response (PR). ORR for WM=CR/PR/very good partial response (VGPR)/minor response (MR). Response assessed per revised Lugano Classification for MZL \&per IWWM for WM participants. Per Lugano criteria CR=complete disappearance of all evidence of disease \& disease-related symptoms. PR=regression of measurable disease \& no new disease sites. Regression=≥50% decrease in the sum of the products of the diameters (SPD) of index
Conditions Studied
Interventions
- DRUG Umbralisib
Study Locations (4)
District of Columbia
- TG Therapeutics Investigational Trial Site - Washington D.C.
Massachusetts
- TG Therapeutics Investigational Trial Site - Boston
New Jersey
- TG Therapeutics Investigational Trial Site - Hackensack
New York
- TG Therapeutics Investigational Trial Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2022-02-15 |
| Phase | Phase 2 |
What the finished NCT03364231 record still lists
NCT03364231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 102-participant average among 49 other Marginal Zone Lymphoma trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Marginal Zone Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Umbralisib is the first listed.
NCT03364231 reports a single indexed study location in District of Columbia, Massachusetts, New Jersey.
Frequently Asked Questions
What is clinical trial NCT03364231 about?
NCT03364231 is a clinical study titled "Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma". This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded to standard treatment.
What is the current status of trial NCT03364231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2017-11-30. Estimated completion is 2022-02-15.
What conditions does trial NCT03364231 study?
This clinical trial studies the following conditions: Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Non Follicular Indolent Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03364231?
The interventions under investigation include: Umbralisib (DRUG).
Who is sponsoring clinical trial NCT03364231?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03364231 being conducted?
This trial has 4 study locations across District of Columbia, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Marginal Zone Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03364231's enrollment target sits among peer trials
21 46th of 49 higher than 4 of 49 other Marginal Zone Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Marginal Zone 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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