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NCT01980628 · ClinicalTrials.gov registry record · Phase 2
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
A Phase 2 study of Marginal Zone Lymphoma and B-cell Lymphoma, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT01980628: Completed Phase 2 study of Marginal Zone Lymphoma and B-cell Lymphoma, sponsored by Pharmacyclics.
NCT01980628 is a Phase 2 study of Marginal Zone Lymphoma and B-cell Lymphoma that has completed, run by Pharmacyclics. The registered enrollment target is 63 participants, below the 101-participant average among 49 other Marginal Zone Lymphoma trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980628, a Phase 2 study of Marginal Zone Lymphoma and B-cell Lymphoma, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).
Primary Outcome
ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC). Per Cheson: CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.
Conditions Studied
Interventions
- DRUG ibrutinib
Study Locations (20)
New York
- Site Reference ID/Investigator# 350 - New Hyde Park
- Site Reference ID/Investigator# 745 - New York
- Site Reference ID/Investigator # 200 - New York
- Site Reference ID/Investigator # 407 - New York
California
- Site Reference ID/Investigator# 047 - Duarte
- Site Reference ID/Investigator# 377 - Santa Monica
Pays de la Loire Region
- Site Reference ID/Investigator# 749 - La Roche-sur-Yon
- Site Reference ID/Investigator# 736 - Nantes
Arizona
- Site Reference ID/Investigator# 837 - Tucson
Florida
- Site Reference ID/Investigator# 763 - West Palm Beach
Georgia
- Site Reference ID/Investigator# 033 - Atlanta
Illinois
- Site Reference ID/Investigator# 370 - Chicago
Michigan
- Site Reference ID/Investigator# 195 - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-12 |
| Est. Completion | 2017-10-02 |
| Phase | Phase 2 |
What the finished NCT01980628 record still lists
NCT01980628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 101-participant average among 49 other Marginal Zone Lymphoma trials with a reported enrollment target (38% lower).
The record links to 2 conditions, with Marginal Zone Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which ibrutinib is the first listed.
NCT01980628 names 20 study sites across 15 states, led by New York, California, Pays de la Loire Region.
Frequently Asked Questions
What is clinical trial NCT01980628 about?
NCT01980628 is a clinical study titled "Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma". Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).
What is the current status of trial NCT01980628?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2013-12. Estimated completion is 2017-10-02.
What conditions does trial NCT01980628 study?
This clinical trial studies the following conditions: Marginal Zone Lymphoma, B-cell Lymphoma.
What interventions are being tested in trial NCT01980628?
The interventions under investigation include: ibrutinib (DRUG).
Who is sponsoring clinical trial NCT01980628?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01980628 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. 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 NCT01980628's enrollment target sits among peer trials
63 17th of 49 higher than 33 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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