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NCT00891839 · ClinicalTrials.gov registry record · Phase 2

Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma

A Phase 2 study, sponsored by Cephalon.

Completed
Registry status
Phase 2
Development phase
45
Enrollment target

NCT00891839: Completed Phase 2 study, sponsored by Cephalon.

NCT00891839 is a Phase 2 study that has completed, run by Cephalon. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00891839, a Phase 2 study, has completed, sponsored by Cephalon.

COMPLETED
Registry status
Phase 2
Development phase
45 participants
Enrollment target

Study Summary

The purpose of this study is to determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.

Primary Outcome

The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed. 95%

Interventions

  • DRUG Rituximab
  • DRUG Bendamustine

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2009-06
Est. Completion 2014-05
Phase Phase 2
Cephalon

64 total trials

What the finished NCT00891839 record still lists

NCT00891839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).

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

NCT00891839 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00891839 about?

NCT00891839 is a clinical study titled "Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma". The purpose of this study is to determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.

What is the current status of trial NCT00891839?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2009-06. Estimated completion is 2014-05.

What interventions are being tested in trial NCT00891839?

The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG).

Who is sponsoring clinical trial NCT00891839?

This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00891839's enrollment target sits among peer trials

45 1296th of 2000 higher than 679 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 NCT00891839, the US trial registry maintained by the National Library of Medicine. NCT00891839 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.