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

Stopped early · Phase 2

Conditions studied: Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3b, Transformed Lymphoma / DLBCL

In brief

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.

Key facts

Study ID

NCT02855359

Run by

Seagen Inc.

People needed

24

Starts

2016-08-01

Expected to finish

2018-05-15

Last updated by the study team

2019-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Norton Cancer Institute — Louisville, Kentucky, United States
• Montgomery Cancer Center — Mount Sterling, Kentucky, United States
• Tulane University Hospital and Clinic — New Orleans, Louisiana, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
• Hattiesburg Clinic (Forrest General Hospital) — Hattiesburg, Mississippi, United States
• Research Medical Center — Kansas City, Missouri, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Mount Sinai Hospital — New York, New York, United States
• Montefiore Medical Center - Bronx — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Regional Medical Oncology Center — Wilson, North Carolina, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• University Hospitals Seidman Cancer Center — Cleveland, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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