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NCT01980654 · ClinicalTrials.gov registry record · Phase 2

Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma

A Phase 2 study, sponsored by Pharmacyclics.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT01980654: Completed Phase 2 study, sponsored by Pharmacyclics.

NCT01980654 is a Phase 2 study that has completed, run by Pharmacyclics. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01980654, a Phase 2 study, has completed, sponsored by Pharmacyclics.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).

Primary Outcome

Number of subjects achieving the best overall responses of CR or PR prior to the initiation of the next line of antineoplastic therapy as assessed by investigator per the Cheson et al, 2007 criteria. Target lesions are measured by CT, unless MRI is used as the assessment modality for lesions in anatomical locations not amenable to CT. CR is defined as the disappearance of all evidence of disease. PR is defined as \>=50% decrease in the sum of the product of the diameters of up to 6 largest domin

Interventions

  • DRUG Ibrutinib
  • DRUG rituximab

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2013-12
Est. Completion 2017-11
Phase Phase 2
Pharmacyclics

54 total trials

What the finished NCT01980654 record still lists

NCT01980654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.

NCT01980654 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01980654 about?

NCT01980654 is a clinical study titled "Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma". This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).

What is the current status of trial NCT01980654?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2013-12. Estimated completion is 2017-11.

What interventions are being tested in trial NCT01980654?

The interventions under investigation include: Ibrutinib (DRUG), rituximab (DRUG).

Who is sponsoring clinical trial NCT01980654?

This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01980654's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01980654, the US trial registry maintained by the National Library of Medicine. NCT01980654 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.