This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Part B Outcome Measure: Complete Response Rate (CR)
Study did not progress to Part B.
Time frame: N/A - Endpoint not assessed
Part A and Part B Outcome Measure: Incidence of Adverse Events
Part A data only; study did not progress to Part B.
Time frame: 54.7 weeks
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.
Time frame: Up to 183 days
Event-free Survival (EFS) Between Study Arms in Part B
Study did not progress to Part B
Time frame: N/A - Endpoint not assessed
Progression-free Survival (PFS) Between Study Arms in Part B
Study did not progress to Part B.
Time frame: N/A - Endpoint not assessed
Overall Survival (OS) Between Study Arms in Part B
Study did not progress to Part B.
Time frame: N/A - Endpoint not assessed
Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B
Study did not progress to Part B.
Time frame: N/A - Endpoint not assessed
Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
Study did not progress to Part B.
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50 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)
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
University of Alabama at Birmingham
Birmingham, Alabama, United States
Saint Bernards Cancer Center
Jonesboro, Arkansas, United States
City of Hope
Duarte, California, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
University of Colorado Health Memorial Hospital
Colorado Springs, Colorado, United States
Poudre Valley Hospital Harmony Campus
Fort Collins, Colorado, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
...and 25 more locations
Time frame: N/A - Endpoint not assessed