Previously untreated, poor-risk (International Prognostic Index [IPI] =3) diffuse large B-cell lymphoma (DLBCL).
Conditions
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) and the following histologies; refer to the World Health Organization (WHO) 2016 classification: a. DLBCL associated with chronic inflammation b. Epstein-Barr virus positive (EBV+) of the elderly c. T-cell/histiocyte-rich DLBCL 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - The primary objective of the Phase 1 portion of the study is to evaluate the safety and tolerability of Avadomide (CC-122) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy and the anti-CD20 monoclonal antibody rituximab (R CHOP) given in 21-day treatment cycles (R-CHOP-21) for first-line treatment of patients with poor-risk (IPI =3) DLBCL in order to identify an appropriate dose and schedule for further investigation in Phase 2 - The primary objective of the Phase 2 portion of the study is to evaluate the rate of complete response when adding Avadomide (CC-122) to the standard R-CHOP-21 regimen in first-line treatment of patients with poor-risk DLBCL.;Secondary Objective: - The secondary objective in Phase 1 is to evaluate early signals of efficacy - The secondary objectives in Phase 2 are : To characterize additional efficacy parameters such as progression-free survival (PFS) and overall survival (OS) To further describe the safety and tolerability associated with Avadomide (CC-122) in combination with R-CHOP-21 in this setting To evaluate biomarkers which are predictive of clinical response to Avadomide (CC-122), when administered in combination with R-CHOP-21 ;Primary end point(s): Phase 1: Maximum Tolerated Dose/Maximum Administered Dose (MTD/MAD) Phase 2: Complete Response Rate (CRR) ;Timepoint(s) of evaluation of this end point: End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Objective Response Rate (ORR) -ORR by Predictive Gene Signature -Progression-free Survival (PFS) -Event-free Survival (EFS) -Overall Survival -Safety ;Timepoint(s) of evaluation of this end point: Endpoints will be measured throughout the treatment and up to 24 months as applicable (please refer to table 4 in the protocol) | — |
Countries
Belgium, Canada, Spain, United States
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed