A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Overview
- Phase
- Phase 3
- Intervention
- doxorubicin
- Conditions
- Anaplastic Large-Cell Lymphoma
- Sponsor
- Seagen Inc.
- Enrollment
- 452
- Locations
- 144
- Primary Endpoint
- Progression-free Survival Per Independent Review Facility (IRF)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
- •Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion Criteria
- •History of another primary invasive malignancy that has not been in remission for at least 3 years
- •Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
- •History of progressive multifocal leukoencephalopathy (PML)
- •Cerebral/meningeal disease related to the underlying malignancy
Arms & Interventions
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
Intervention: doxorubicin
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
Intervention: prednisone
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
Intervention: vincristine
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
Intervention: cyclophosphamide
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Intervention: brentuximab vedotin
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Intervention: doxorubicin
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Intervention: prednisone
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Intervention: cyclophosphamide
Outcomes
Primary Outcomes
Progression-free Survival Per Independent Review Facility (IRF)
Time Frame: Up to 60 months
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.
Secondary Outcomes
- Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)(Up to 60 months)
- Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)(Up to 8.34 months)
- Overall Survival (OS)(Up to 90 months)
- Objective Response Rate (ORR) Per IRF at End of Treatment(Up to 8.34 months)
- Incidence of Adverse Events (AEs)(Up to 8.28 months)
- Incidence of Laboratory Abnormalities(Up to 8.28 months)