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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2013-004054-21-CZ
• Date of registration: 28/08/2014
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: Study of lenalidomide plus R-CHOP chemotherapy versus placebo plus R-CHOP chemotherapy in untreated diffuse large B-cell lymphoma
• Scientific title: 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. - ROBUST
• Date of first enrolment: 06/11/2014
• Target sample size: 560
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004054-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

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

Intervention(s)

Trade Name: Revlimid 2.5 mg hard capsules
Product Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Revlimid 5 mg hard capsules
Product Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Revlimid 10 mg hard capsules
Product Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Revlimid 15 mg hard capsules
Product Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Concentration unit: mg milligra

Primary Outcome(s)

Primary end point(s): -Progression-free Survival (PFS)

Secondary Objective: The secondary objective of this study is to compare the safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin,vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in subjects who have previously untreated ABC type DLBCL

Timepoint(s) of evaluation of this end point: -This will be analyzed after a total of 192 PFS events in the ITT population have been observed. This is estimated to occur approximately 42 months after the first subject is randomized.
-An interim analysis for futility is planned after a total of 96 PFS events in the ITT population have been observed. This is estimated to occur approximately 28 months after the first subject is randomized.

Main Objective: To compare the efficacy of lenalidomide, rituximab, cyclophosphamide, doxorubicin,vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in subjects who have previously untreated ABC type DLBCL.

Secondary Outcome(s)

Secondary end point(s): Key secondary endpoint
-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 EuroQuol 5 Dimension Scale (EQ-5D) and the Functional Assessment of Cancer Therapy for Patients with Lymphoma (FACT Lym) standardized measures of health status.

Timepoint(s) of evaluation of this end point: - At time of primary endpoint evaluation (applies for all secondary end points listed above)

Secondary ID(s)

2013-004054-21-ES

CC-5013-DLC-002

Source(s) of Monetary Support

Celgene Corporation

Ethics review

Status: Approved
Approval date:
Contact: