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NCT01657331 · ClinicalTrials.gov registry record · Phase 1

Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)

A Phase 1 study, sponsored by Columbia University.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT01657331: Completed Phase 1 study, sponsored by Columbia University.

NCT01657331 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 65 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

NCT01657331, a Phase 1 study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at two subsites in Canada.

Primary Outcome

This is to measure the highest dose that does not cause unacceptable side effects with the combination of brentuximab vedotin and bendamustine.

Interventions

  • DRUG Brentuximab Vedotin
  • DRUG Bendamustine
  • DRUG Neulasta

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2012-07
Est. Completion 2018-06
Phase Phase 1
Columbia University

958 total trials

What the finished NCT01657331 record still lists

NCT01657331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 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 Brentuximab Vedotin is the first listed.

NCT01657331 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01657331 about?

NCT01657331 is a clinical study titled "Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)". This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Patients will be ...

What is the current status of trial NCT01657331?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2012-07. Estimated completion is 2018-06.

What interventions are being tested in trial NCT01657331?

The interventions under investigation include: Brentuximab Vedotin (DRUG), Bendamustine (DRUG), Neulasta (DRUG).

Who is sponsoring clinical trial NCT01657331?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01657331's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 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 NCT01657331, the US trial registry maintained by the National Library of Medicine. NCT01657331 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.