Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma
Stopped early · Phase 2
Conditions studied: Lymphoma, B-cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Grade 3b, Follicular Lymphoma, Grade 3b
In brief
The purpose of this randomized, open-label study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1 ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or RICE alone. The study will assess whether there is a difference between the 2 groups in the side effects that are reported and the number of patients who achieve complete remission at the end of their study treatment.
Key facts
- Study ID
- NCT02592876
- Run by
- Seagen Inc.
- People needed
- 81
- Starts
- 2015-10-01
- Expected to finish
- 2018-04-20
- Last updated by the study team
- 2019-05-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pathologically confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL; including de novo and transformed DLBCL) or Grade 3b follicular lymphoma
- Available representative tissue from the most recent biopsy after the last therapy; if such tissue is not available, a fresh biopsy must be obtained
- Received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy, and radiotherapy in a limited field or as part of the frontline treatment plan are permitted.
- Achieved a response of stable disease, partial response, or complete response following the last cycle of frontline treatment. In addition, patients must have relapsed less than or equal to 6 months from the completion of frontline therapy at the time of initial dosing in this clinical trial.
- Considered eligible for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
- Fluorodeoxyglucose (FDG)-avid disease by positive emission tomography (PET), and measurable disease greater than 1.5 cm in diameter
- Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2
- Adequate kidney and hematologic function assessed from baseline laboratory data
You may not qualify if…
- Previous history of indolent lymphoma treated with more than 1 multi-agent chemotherapy regimen or previous cancer therapy for recurrent DLBCL or Grade 3b follicular lymphoma
- History of autologous or allogeneic stem cell transplant
- History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year
- History of progressive multifocal leukoencephalopathy (PML)
- Cerebral/meningeal disease related to the underlying malignancy that has not been definitively treated
- Known urinary tract obstruction
- Patients with the following ocular conditions: corneal disorders, monocular vision (i.e., 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 Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- City of Hope National Medical Center — Duarte, California, United States
- Scripps Mercy Cancer Center — San Diego, California, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Shands Cancer Center / University of Florida — Gainesville, Florida, United States
- University of Miami — Miami, Florida, United States
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
- Winship Cancer Institute / Emory University School of Medicine — Atlanta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- University of Chicago — Chicago, Illinois, United States
- Cardinal Bernardin Cancer Center / Loyola University Medical Center — Maywood, Illinois, United States
- University of Kansas Cancer Center — Westwood, Kansas, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- UNC Lineberger Comprehensive Cancer Center / University of North Carolina — Chapel Hill, North Carolina, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
- San Antonio Military Medical Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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