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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 is a Phase 2 study that was terminated before completion, run by Seagen. The registered enrollment target is 87 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01925612
The ClinicalTrials.gov registry entry for NCT01925612 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, which has 84 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which cyclophosphamide is the first listed.
NCT01925612 reports 0 study locations.
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.
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