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.
In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects). The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
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
Complete Remission Rate
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Time frame: Up to 6 months
Incidence of Adverse Events
Number (count) of participants that experienced at least 1 adverse event.
Time frame: Up to 6 months
Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Time frame: Up to 6 months
Objective Response Rate
Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
Time frame: Up to 6 months
Progression-free Survival
Median progression-free survival (in months) and observed minimum-maximum range.
Time frame: Up to approximately 4 years
Overall Survival
Median overall survival (in months) and observed minimum-maximum range.
Time frame: Up to approximately 4 years
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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
...and 41 more locations