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NCT01077518 · ClinicalTrials.gov registry record · Phase 3

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 3
Development phase
346
Enrollment target

NCT01077518 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 346 participants.

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The verdict

NCT01077518, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 3
Development phase
346 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Interventions

  • DRUG Ofatumumab
  • DRUG Bendamustine infusion
  • DRUG Ofatumumab and Bendamustine infusions (Arm A)
  • DRUG Bendamustine infusion (Arm B)

Trial Details

FieldValue
Enrollment Target 346 participants
Start Date 2010-08-26
Est. Completion 2018-12-26
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01077518

The ClinicalTrials.gov registry entry for NCT01077518 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 346 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Ofatumumab is the first listed.

NCT01077518 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01077518 about?

NCT01077518 is a clinical study titled "Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy". The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

What is the current status of trial NCT01077518?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2010-08-26. Estimated completion is 2018-12-26.

What interventions are being tested in trial NCT01077518?

The interventions under investigation include: Ofatumumab (DRUG), Bendamustine infusion (DRUG), Ofatumumab and Bendamustine infusions (Arm A) (DRUG), Bendamustine infusion (Arm B) (DRUG).

Who is sponsoring clinical trial NCT01077518?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.