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NCT02004522 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

A Phase 3 study, sponsored by SecuraBio.

Completed
Registry status
Phase 3
Development phase
319
Enrollment target

NCT02004522: Completed Phase 3 study, sponsored by SecuraBio.

NCT02004522 is a Phase 3 study that has completed, run by SecuraBio. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02004522, a Phase 3 study, has completed, sponsored by SecuraBio.

COMPLETED
Registry status
Phase 3
Development phase
319 participants
Enrollment target

Study Summary

A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Primary Outcome

The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.

Interventions

  • DRUG Duvelisib
  • DRUG Ofatumumab

Trial Details

FieldValue
Enrollment Target 319 participants
Start Date 2013-11
Est. Completion 2021-06
Phase Phase 3
SecuraBio

15 total trials

What the finished NCT02004522 record still lists

NCT02004522 is an interventional study that assigns participants to a tested intervention. The registered 319 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 (59% lower).

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

NCT02004522 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02004522 about?

NCT02004522 is a clinical study titled "A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)". A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

What is the current status of trial NCT02004522?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2013-11. Estimated completion is 2021-06.

What interventions are being tested in trial NCT02004522?

The interventions under investigation include: Duvelisib (DRUG), Ofatumumab (DRUG).

Who is sponsoring clinical trial NCT02004522?

This trial is sponsored by SecuraBio, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02004522's enrollment target sits among peer trials

319 1087th of 2000 higher than 914 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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Source: ClinicalTrials.gov NCT02004522, the US trial registry maintained by the National Library of Medicine. NCT02004522 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.