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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004054-21-IE

Enrollment

560

Registered

2014-08-14

Start date

2014-10-27

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Cla

Interventions

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 Concentr

Eligibility

Sex/Gender

All

Inclusion 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

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 hepatitis C, or subjects with an active hepatitis infection (testing is required) -Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF =2. - T-cell/histiocyte rich Diffuse Large B-Cell Lymphoma (DLBCL) cases -Post-transplant Lymphoproliferative Disorder (PTLPD) cases

Design outcomes

Primary

Measure	Time frame
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 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;Primary end point(s): -Progression-free Survival (PFS);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.	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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 EuroQol 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)	—

Measure

Time frame

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 EuroQol 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)

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Countries

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

Public ContactClinicalTrialDisclosure

Celgene Corporation

ClinicalTrialDisclosure@celgene.com+1 913709-6862

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026