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NCT01594229 · ClinicalTrials.gov registry record · Phase 1

A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 1 study, sponsored by AbbVie.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT01594229: Completed Phase 1 study, sponsored by AbbVie.

NCT01594229 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01594229, a Phase 1 study, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when administered in combination with Bendamustine/Rituximab following a dose escalation scheme, with the objective of defining the dose limiting toxicity and the maximum tolerated dose.

Primary Outcome

Protocol-defined events, which can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, or concomitant medication, will be considered a dose limiting toxicity

Interventions

  • DRUG Rituximab
  • DRUG Bendamustine
  • DRUG ABT-199

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2012-05-21
Est. Completion 2020-07-14
Phase Phase 1
AbbVie

526 total trials

What the finished NCT01594229 record still lists

NCT01594229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.

NCT01594229 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01594229 about?

NCT01594229 is a clinical study titled "A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma". This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will evaluate the safety and pha...

What is the current status of trial NCT01594229?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-05-21. Estimated completion is 2020-07-14.

What interventions are being tested in trial NCT01594229?

The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG), ABT-199 (DRUG).

Who is sponsoring clinical trial NCT01594229?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01594229's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01594229, the US trial registry maintained by the National Library of Medicine. NCT01594229 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.