This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
452
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
Progression-free Survival Per Independent Review Facility (IRF)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Time frame: Up to 60 months
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Time frame: Up to 60 months
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Time frame: Up to 8.34 months
Overall Survival (OS)
The time from randomization to death due to any cause.
Time frame: Up to 90 months
Objective Response Rate (ORR) Per IRF at End of Treatment
The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Time frame: Up to 8.34 months
Incidence of Adverse Events (AEs)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
Shands Cancer Center / University of Florida
Gainesville, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Holden Comprehensive Cancer Center / University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 134 more locations
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 8.28 months
Incidence of Laboratory Abnormalities
Number of participants who experienced a Grade 3 or higher laboratory toxicity.
Time frame: Up to 8.28 months