Clinical trial NCT02855359: Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Official title: An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diffuse, Large B-Cell, Lymphoma
Follicular Lymphoma, Grade 3b
Transformed Lymphoma / DLBCL
Keywords: Antibodies, Monoclonal
SGN-19A
Denintuzumab Mafodotin
DLBCL
Antibody-Drug Conjugate
Antigens, CD19
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Immunotherapy
Lymphatic Diseases
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Monomethyl auristatin F
Neoplasms
Neoplasms by Histologic Type
Transformed Lymphoma / DLBCL
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotic, Antineoplastic
Antimitotic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Phytogenic Antirheumatic Agents
Glucocorticoids
Drug Therapy
Follicular Lymphoma Grade 3b
immunosuppressive agents
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;

  * patients must have high intermediate or high risk disease
* Tumor tissue available from most recent biopsy to determine cell of origin
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
* Eastern Cooperative Oncology Group performance status ≤2
* Age 18 years or older
* Adequate study baseline laboratory parameters

Exclusion Criteria:

* Previous history of treated indolent lymphoma
* History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
* History of progressive multifocal leukoencephalopathy
* Cerebral/meningeal disease related to the underlying malignancy
* Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment

Primary outcomes:
measure: Part B Outcome Measure: Complete Response Rate (CR)
timeFrame: N/A - Endpoint not assessed
measure: Part A and Part B Outcome Measure: Incidence of Adverse Events
timeFrame: 54.7 weeks
measure: Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
timeFrame: Up to 183 days
Secondary outcomes:
measure: Event-free Survival (EFS) Between Study Arms in Part B
timeFrame: N/A - Endpoint not assessed
measure: Progression-free Survival (PFS) Between Study Arms in Part B
timeFrame: N/A - Endpoint not assessed
measure: Overall Survival (OS) Between Study Arms in Part B
timeFrame: N/A - Endpoint not assessed
measure: Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B
timeFrame: N/A - Endpoint not assessed
measure: Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B
timeFrame: N/A - Endpoint not assessed
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Jonesboro
country: United States
facility: Saint Bernards Cancer Center
state: Arkansas
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Colorado Springs
country: United States
facility: University of Colorado Health Memorial Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital Harmony Campus
state: Colorado
city: Macon
country: United States
facility: Central Georgia Cancer Care
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic (Forrest General Hospital)
state: Mississippi
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Bronx
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Wilson
country: United States
facility: Regional Medical Oncology Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology / Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Health - Baylor University Medical Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial Hospital - Temple
state: Texas
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Olympia
country: United States
facility: Vista Oncology INC PS
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation
Study officials:
affiliation: Seagen Inc.
name: Juan Pinelli, PA-C, MMSc.
role: STUDY_DIRECTOR
References: