Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Stopped early · Phase 2
Conditions studied: Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse
In brief
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.
Key facts
- Study ID
- NCT01925612
- Run by
- Seagen Inc.
- People needed
- 87
- Starts
- 2013-08-01
- Expected to finish
- 2017-05-01
- Last updated by the study team
- 2018-06-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
- International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
- Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL
You may not qualify if…
- Previous history of treated indolent lymphoma
- History of another primary malignancy that has not been in remission for 3 years
Where it is running
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Comprehensive Blood and Cancer Center — Bakersfield, California, United States
- City of Hope National Medical Center — Duarte, California, United States
- Sansum Clinic — Santa Barbara, California, United States
- Stanford Cancer Center — Stanford, California, United States
- Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
- Augusta University — Augusta, Georgia, United States
- Cardinal Bernardin Cancer Center / Loyola University Medical Center — Maywood, Illinois, United States
- Illinois Cancer Specialists / Advocate Lutheran General Hospital — Niles, Illinois, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- Johns Hopkins Medical Center — Baltimore, Maryland, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Billings Clinic Cancer Research — Billings, Montana, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Summit Medical Group — Morristown, New Jersey, United States
- Jersey Shore University Medical Center — Neptune City, New Jersey, United States
- New York Oncology Hematology, P.C. — Albany, New York, United States
- Mid Ohio Oncology/Hematology Inc — Columbus, Ohio, United States
- Willamette Valley Cancer Institute and Research Center — Springfield, Oregon, United States
- Northwest Cancer Specialists, P.C. — Tualatin, Oregon, United States
- Saint Francis Hospital / Bon Secours — Greenville, South Carolina, United States
- Tennessee Cancer Specialists — Knoxville, Tennessee, United States
- Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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