Non Hodgkin Lymphoma Clinical Trial

Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

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.

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Full 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).

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT02855359

Recruitment Status:

Terminated

Sponsor:

Seagen Inc.

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There are 35 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Saint Bernards Cancer Center
Jonesboro Arkansas, 72401, United States
City of Hope
Duarte California, 91010, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley California, 92708, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
University of Colorado Health Memorial Hospital
Colorado Springs Colorado, 80909, United States
Poudre Valley Hospital Harmony Campus
Fort Collins Colorado, 80528, United States
Central Georgia Cancer Care
Macon Georgia, 31201, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Montgomery Cancer Center
Mount Sterling Kentucky, 40353, United States
Tulane University Hospital and Clinic
New Orleans Louisiana, 70122, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Hattiesburg Clinic (Forrest General Hospital)
Hattiesburg Mississippi, 39401, United States
Research Medical Center
Kansas City Missouri, 64132, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Montefiore Medical Center - Bronx
Bronx New York, 10467, United States
Mount Sinai Hospital
New York New York, 10029, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Regional Medical Oncology Center
Wilson North Carolina, 27893, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
University Hospitals Seidman Cancer Center
Cleveland Ohio, 44106, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Hollings Cancer Center
Charleston South Carolina, 29425, United States
Tennessee Oncology / Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Baylor Health - Baylor University Medical Center
Dallas Texas, 75246, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Scott and White Memorial Hospital - Temple
Temple Texas, 76508, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Vista Oncology INC PS
Olympia Washington, 98502, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
Ponce Medical School Foundation
Ponce , 00716, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT02855359

Recruitment Status:

Terminated

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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