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NCT01492088 · ClinicalTrials.gov registry record · Phase 1
Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
A Phase 1 study of Relapsed or Refractory Hodgkin Lymphoma and Relapsed or Refractory Anaplastic Large-cell Lymphoma, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 18
- Study locations
NCT01492088: Completed Phase 1 study of Relapsed or Refractory Hodgkin Lymphoma and Relapsed or Refractory Anaplastic Large-cell Lymphoma, sponsored by Millennium Pharmaceuticals.
NCT01492088 is a Phase 1 study of Relapsed or Refractory Hodgkin Lymphoma and Relapsed or Refractory Anaplastic Large-cell Lymphoma that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 18 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01492088, a Phase 1 study of Relapsed or Refractory Hodgkin Lymphoma and Relapsed or Refractory Anaplastic Large-cell Lymphoma, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant
Conditions Studied
Interventions
- DRUG Brentuximab vedotin
Study Locations (18)
Other
- - Bordeaux
- - Lyon
- - Paris
- - Berlin
- - Frankfurt
- - Giessen
- - Halle
- - Münster
- - Padua
- - Roma
- - Mexico City
- - Rotterdam
- - Barcelona
- - London
Colorado
- - Aurora
Missouri
- - Kansas City
New York
- - New York
Texas
- - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-04-16 |
| Est. Completion | 2018-04-12 |
| Phase | Phase 1 |
What the finished NCT01492088 record still lists
NCT01492088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Relapsed or Refractory Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Brentuximab vedotin is the first listed.
NCT01492088 lists 18 locations in 5 states (Other, Colorado, Missouri).
Frequently Asked Questions
What is clinical trial NCT01492088 about?
NCT01492088 is a clinical study titled "Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma". The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.
What is the current status of trial NCT01492088?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-04-16. Estimated completion is 2018-04-12.
What conditions does trial NCT01492088 study?
This clinical trial studies the following conditions: Relapsed or Refractory Hodgkin Lymphoma, Relapsed or Refractory Anaplastic Large-cell Lymphoma.
What interventions are being tested in trial NCT01492088?
The interventions under investigation include: Brentuximab vedotin (DRUG).
Who is sponsoring clinical trial NCT01492088?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01492088 being conducted?
This trial has 18 study locations across Colorado, Missouri, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01492088's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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