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NCT01805037 · ClinicalTrials.gov registry record · Phase 1
Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01805037: Clinical Trial Phase 1 study, sponsored by Northwestern University.
NCT01805037 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805037, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate how safe and effective the combination of two different drugs (brentuximab vedotin and rituximab) is in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). This study is investigating the combination of brentuximab vedotin and rituximab as a first treatment for lymphoma patients
Primary Outcome
To identify the recommended phase 2 dose (RP2D)/maximum tolerated dose (MTD) of brentuximab vedotin in combination with rituximab. The dose limiting toxicity monitoring period for brentuximab vedotin and rituximab is first 21 days (during induction).The RP2D/MTD will be defined as the highest dose of brentuximab vedotin that causes dose limiting toxicities (DLTs) in \<2 of 6 patients. The Phase I portion of the study follows a 3+3 design. Brentuximab has two dose levels: Level 1 (starting dose)
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL rituximab
- DRUG brentuximab vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-03-05 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 1 |
Why NCT01805037 stopped before completion
NCT01805037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01805037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805037 about?
NCT01805037 is a clinical study titled "Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas". The purpose of this study is to evaluate how safe and effective the combination of two different drugs (brentuximab vedotin and rituximab) is in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type tha...
What is the current status of trial NCT01805037?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-03-05. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT01805037?
The interventions under investigation include: laboratory biomarker analysis (OTHER), rituximab (BIOLOGICAL), brentuximab vedotin (DRUG).
Who is sponsoring clinical trial NCT01805037?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01805037's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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