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: 22.0 Level: LLT Classification code 10012859 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage II System Organ Class: 100000004864; MedDRA version: 21.0 Level: LLT Classification code 10012855 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) System Organ Class: 100000004864; MedDRA version: 21.1 Level: LLT Classification code 10012860 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage III System Organ Class: 100000004864; MedDRA version: 21.0 Level: LLT Classification code 10012861 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage IV System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004054-21-CZ
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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 > 80years, 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 otherwise
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=7.5 g/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)
-Seropositive for HCV, with chronic hepatisc 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified