Study Title
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL) (NCT01925612)
Trial Description
This study has 2 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of the antibody-drug conjugate or ADC brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as A+RCHOP) in patients with DLBCL that have never been treated. In this trial, 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 A+RCHP) in patients with CD30-positive DLBCL that have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.
This trial is sponsored by Seattle Genetics. [1]
Study Data
- Condition: Lymphoma
- Interventions:
- Drugs used in this trial:
- brentuximab vedotin (Adcetris®; Seattle Genetics, Inc.)
- rituximab (Rituxam®; Biogen, Inc,/ Genentech, Inc.)
- vincristine (Oncovin® Genus Pharmaceuticals)
- cyclophosphamide (Cytoxan®; Bristol-Myers Squibb Company)
- prednisone (Orapred®; Concordia Healthcare Corp.)
- doxorubicin (Doxil®; TTY Bio pharmacy Company Limited)
- Drugs used in this trial:
- Phase: II
- Estimated Enrollment: 125
- Start: August 2013
- Estimated Completion: December 2018
- Last verified: June 2013
Study Schematic
(Coming soon)
Last Editorial review: July 17, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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