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

JRCT ID: jRCT2061220104

Registered date:02/03/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Previously untreated, activated B-cell (ABC) type diffuse large B- cell lymphoma
• Date of first enrollment: 10/09/2015
• Target sample size: 46
• Countries of recruitment: Australia,Japan,Belgium,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,France,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Republic of Korea,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Portugal,Japan,Russian Federation,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,Turkey,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Progression-free Survival (PFS)

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Hayakawa Jin
• Secondary ID(s): NCT02285062