Study of lenalidomide plus R-CHOP chemotherapy versus placebo plus R-CHOP chemotherapy in untreated diffuse large B-cell lymphoma

Phase 1

Conditions: Previously untreated, activated B-cell (ABC) type diffuse large B-cell lymphoma (DLBCL).
MedDRA version: 19.1Level: LLTClassification code 10012859Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage IISystem Organ Class: 100000004864
MedDRA version: 19.1Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864
MedDRA version: 19.1Level: LLTClassification code 10012860Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage IIISystem Organ Class: 100000004864
MedDRA version: 19.1Level: LLTClassification code 10012861Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage IVSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-004054-21-BE

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 560

Inclusion Criteria

-Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL) of the ABC type.
-Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma (DLBCL)
-Measurable Diffuse Large B-Cell Lymphoma (DLBCL) disease by Computed Tomography (CT)
-Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Age from 18. For subjects > 80 years, if their ECOG = 1; each of their individual organ systems scores is = 2 using the Modified Cumulative Illness Rating Scale (CIRS) for co-morbidity; and if they would otherwhise be eligible for full-dose R-CHOP per local practice.
-HCV patients who do not have hepatitis C and who are acceptable for R-CHOP chemotherapy.
- Hemoglobin criterion 11c > = 7.5g/dL
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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 392

Exclusion Criteria

-Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma (DLBCL).
-History of malignancies, other than Diffuse Large B-Cell Lymphoma (DLBCL), unless the patient has been disease free for 5 years or more.
-Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) (testing is at investigator discretion)
- Seropositive for HBV (testing is required)
- Seropostitive for HCV, with chronic hepatis C, or subjects with an active hepatitis infection (testing is required)
-Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF < 45% or peripheral neuropathy grade > =2.
- T cell/histiocyte rich Diffuse Large B-Cell Lymphoma (DLBCL) cases
- Post-transplant Lymphoproliferative Disorder (PTLPD) cases