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NCT01578499 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
NCT01578499: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT01578499 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 131 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578499, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
Study Summary
The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma \[mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) \]compared to that achieved with therapy in the control arm.
Primary Outcome
ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was base
Interventions
- DRUG Brentuximab Vedotin
- DRUG Methotrexate
- DRUG Bexarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2012-06-11 |
| Est. Completion | 2018-07-06 |
| Phase | Phase 3 |
What the finished NCT01578499 record still lists
NCT01578499 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Brentuximab Vedotin is the first listed.
NCT01578499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01578499 about?
NCT01578499 is a clinical study titled "A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)". The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma \[mycosis fungoides (MF) and primary cutaneous anaplastic large ce...
What is the current status of trial NCT01578499?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2012-06-11. Estimated completion is 2018-07-06.
What interventions are being tested in trial NCT01578499?
The interventions under investigation include: Brentuximab Vedotin (DRUG), Methotrexate (DRUG), Bexarotene (DRUG).
Who is sponsoring clinical trial NCT01578499?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01578499's enrollment target sits among peer trials
131 1593rd of 2000 higher than 407 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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