Brentuximab Vedotin in CD30 Positive Epstein Barr Virus (EBV) Positive DLBCL of Elderly (NCT01671813) | Clinical Trial Compass
WithdrawnNot Applicable
Brentuximab Vedotin in CD30 Positive Epstein Barr Virus (EBV) Positive DLBCL of Elderly
Stopped: Terminated by pharmaceutical sponsor - no accrual
0Started 2013-03
Plain-language summary
The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-Cell Lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment that might be given.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed diagnosis of CD30+EBV+DLBCLE (EDLBCLE). Diagnosis will be based on identification of diffuse large cell lymphoma (DLBCL) in biopsy specimens characterized by positivity in the malignant cell population of 2 principal markers:
* CD30 by immunohistochemistry (IHC) and
* Epstein-Barr virus (EBV) by EBER in situ hybridization (ISH)
* Histology slides and pathology material must be available at the site for each patient before enrollment in order to be sent to the Leading Institution of the study for central pathology review and pharmacodynamic studies.
* Patients must have progressive, relapsed or refractory disease after:
* At least one prior systemic anti-lymphoma regimen (chemotherapy or immunotherapy)
* Relapsed or failed autologous or allogeneic stem cell transplant.
* Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form
* Must have at least one site of disease (index lesion) measurable in two dimensions by computed tomography (CT)
* At least 4 weeks since the last chemotherapy, radiation therapy, immunotherapy or any investigational non-immunotherapy products with clinical evidence of recovery from any toxicity associated with such treatment
* Must meet the following criteria within 4 days before the first dose of study drug:
* Neutrophils ≥1,000/ul
* Hemoglobin ≥ 8 g/dL
* Platelets≥ 50.0x10\^9 /L
* Total bilirubin ≤ 1.5 x upper normal limit, or ≤ 5 x upper normal limit if docu…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 36 months
Trial details
NCT IDNCT01671813
SponsorH. Lee Moffitt Cancer Center and Research Institute