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NCT01925612 · ClinicalTrials.gov registry record · Phase 2
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 2 study, sponsored by Seagen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT01925612: Clinical Trial Phase 2 study, sponsored by Seagen.
NCT01925612 is a Phase 2 study that was terminated before completion, run by Seagen. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925612, a Phase 2 study, was terminated before completion, sponsored by Seagen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study Summary
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups. The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin. The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.
Primary Outcome
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Interventions
- DRUG cyclophosphamide
- DRUG brentuximab vedotin
- DRUG rituximab
- DRUG vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-05-01 |
| Phase | Phase 2 |
Why NCT01925612 stopped before completion
NCT01925612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 4 interventions - of which cyclophosphamide is the first listed.
NCT01925612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01925612 about?
NCT01925612 is a clinical study titled "Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)". This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients w...
What is the current status of trial NCT01925612?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2013-08. Estimated completion is 2017-05-01.
What interventions are being tested in trial NCT01925612?
The interventions under investigation include: cyclophosphamide (DRUG), brentuximab vedotin (DRUG), rituximab (DRUG), vincristine (DRUG).
Who is sponsoring clinical trial NCT01925612?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01925612's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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