Study of Nivolumab in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant
- Conditions
- ymphoma. Non-HodgkinMedDRA version: 17.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003621-28-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL);.
ECOG performance status of 0 -1;
At least one lesion that measures > 1.5 cm;
Prior therapy and screening lab criteria must be met;
Appropriate contraceptive measures must be taken
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Known CNS lymphoma;
History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus;
Prior allogeneic SCT, chest radiation < 24 weeks from study drug, = 1000mg of carmustine (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting t-cell costimulation or immune checkpoint pathways.
Women who are breastfeeding or pregnant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method