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NCT01309789 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

A Phase 1 study, sponsored by Seagen.

Completed
Registry status
Phase 1
Development phase
39
Enrollment target

NCT01309789: Completed Phase 1 study, sponsored by Seagen.

NCT01309789 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01309789, a Phase 1 study, has completed, sponsored by Seagen.

COMPLETED
Registry status
Phase 1
Development phase
39 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.

Interventions

  • DRUG prednisone
  • DRUG cyclophosphamide
  • DRUG brentuximab vedotin

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2011-02
Est. Completion 2017-02-28
Phase Phase 1
Seagen

84 total trials

What the finished NCT01309789 record still lists

NCT01309789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).

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

NCT01309789 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01309789 about?

NCT01309789 is a clinical study titled "A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms". The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label...

What is the current status of trial NCT01309789?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2011-02. Estimated completion is 2017-02-28.

What interventions are being tested in trial NCT01309789?

The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), brentuximab vedotin (DRUG).

Who is sponsoring clinical trial NCT01309789?

This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01309789's enrollment target sits among peer trials

39 1191st of 2000 higher than 804 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 NCT01309789, the US trial registry maintained by the National Library of Medicine. NCT01309789 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.