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

A Phase 1/2 Open-label, Multicenter Study of CC-122 in Combination With R-CHOP-21 for Previously Untreated Poor-Risk (IPI = 3) Diffuse Large B-Cell Lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003778-42-ES

Enrollment

Registered

2017-05-29

Start date

2017-07-31

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously untreated, high-intermediate and high-risk (International Prognostic Index [IPI] = 3) diffuse large B-cell lymphoma (DLBCL).

Interventions

Product Name: CC-122 Product Code: CC-122 Pharmaceutical Form: Capsule, hard INN or Proposed INN: CC-122 Current Sponsor code: CC-122 Other descriptive name: CC-122 formulated capsule F6 Concentration

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) 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

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 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 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 CC-122 in combination with R-CHOP-21 in this setting To evaluate biomarkers which are predictive of clinical response to 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	—

Measure

Time frame

Main Objective: - The primary objective of the Phase 1 portion of the study is to evaluate the safety and tolerability of 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 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 CC-122 in combination with R-CHOP-21 in this setting To evaluate biomarkers which are predictive of clinical response to 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

ClinicalTrialDisclosure@celgene.com+3491422-9000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026