A clinical study to determine how the drug CC-122 works in the body and how safe it is in combination with R-CHOP for previously untreated poor-risk Diffuse Large B-Cell Lymphoma
- Conditions
- Previously untreated, high-intermediate and high-risk (International Prognostic Index [IPI] = 3) diffuse large B-cell lymphoma (DLBCL).Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003778-42-ES
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
1.Subject is = 18 years of age at the time of signing the informed consent form (ICF)
2.Subject has documented, histologically locally confirmed, previously untreated CD20+ DLBCL (NOS) per World Health Organization (WHO) classifications
3.Subject has poor-risk disease defined as International Prognostic Index (IPI) score = 3 (high-intermediate or high-risk classification)
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 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33
The presence of any of the following will exclude a subject from enrollment:
1.Subject is seropositive for or has active viral infection with hepatitis B virus (HBV)
2.Subject is known to be seropositive for, or have an active infection with, hepatitis C virus (HCV)
3.Subject is known to be seropositive for, or have an active infection with, human immunodeficiency virus (HIV)
4.Subject has any neuropathy > Grade 1
5.Subject has impaired cardiac function or clinically significant cardiac diseases
6.Subject has confirmed central nervous system (CNS) involvement by DLBCL
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