Phase 3 Randomized, Double- Blind,Placebo Controlled, MulticenterStudy to Compare the Efficacy and Safety of Lenalidomide(CC-5013) PlusR- CHOP Chemotherapy (R2-CHOP)Versus Placebo Plus R- CHOP Chemotherapy in Subjects with Previously UntreatedActivated B- cell Type Diffuse Large B- cell Lymphoma

Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide(CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects with Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061220104

Enrollment

Registered

2023-03-02

Start date

2015-09-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Previously untreated, activated B-cell (ABC) type diffuse large B- cell lymphoma

Interventions

Experimental: R2-CHOP Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) Active Comparator: R-CHOP Placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type 2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma 3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 5. Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status <= 1; and each organ system score <= 2 using cumulative illness rating scale (CIRS)

Exclusion criteria

Exclusion criteria: 1. Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma 2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more 3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) 4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2

Design outcomes

Primary

Measure	Time frame
Progression-free Survival (PFS)	—

Secondary

Measure	Time frame
-Event-free Survival (EFS) Other secondary endpoints-Overall Survival (OS)-Complete Response (CR)rate -Duration of CR-Time to next lymphoma therapy (TTNLT)-Objective response rate (ORR)-Health-related quality of life (HRQoL) as measured by the EuroQol 5 Dimension Scale (EQ-5D) and the Functional Assessment of Cancer Therapy for Patients with Lymphoma (FACT-Lym) standardized measures of health status	—

Measure

Time frame

-Event-free Survival (EFS) Other secondary endpoints-Overall Survival (OS)-Complete Response (CR)rate -Duration of CR-Time to next lymphoma therapy (TTNLT)-Objective response rate (ORR)-Health-related quality of life (HRQoL) as measured by the EuroQol 5 Dimension Scale (EQ-5D) and the Functional Assessment of Cancer Therapy for Patients with Lymphoma (FACT-Lym) standardized measures of health status

—

Countries

Australia, Belgium, Canada, China, Czech Republic, France, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Republic of Korea, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United States

Contacts

Public ContactJin Hayakawa

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026