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
- Conditions
- Previously untreated, activated B-cell (ABC) type diffuse large B- cell lymphoma
- Registration Number
- JPRN-jRCT2061220104
- Lead Sponsor
- Hayakawa Jin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 46
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS)
- Secondary Outcome Measures
Name Time Method -Event-free Survival (EFS)<br>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