Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 January 2021 |
Main ID: |
EUCTR2013-004054-21-NL |
Date of registration:
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08/12/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of lenalidomide plus R-CHOP chemotherapy versus placebo plus R-CHOP chemotherapy in untreated diffuse large B-cell lymphoma
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Scientific title:
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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:
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19/05/2015 |
Target sample size:
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560 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004054-21 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Canada
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China
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Czech Republic
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Czechia
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France
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Ireland
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Italy
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Japan
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Korea, Republic of
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Netherlands
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New Zealand
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Poland
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Portugal
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Spain
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Switzerland
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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ClinicalTrialDisclosure
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Address:
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9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
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+1-888-260-1599 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Name:
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ClinicalTrialDisclosure
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Address:
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9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
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+1-888-260-1599 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Key inclusion & exclusion criteria
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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 18 -80 years - Age from 18. For subjects >80years, if their ECOG <_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 loacl practice. - HCV patients who do not have hepatitid 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 investigators 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 < 45% or peripheral neuropathy grade > =2. - T-cell/histiocyte rich Diffuse Large B-cell Lymphona (DCBCL) cases - Post-transplant Lymphoproliferative Disorder (PTLPD) cases
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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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
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Intervention(s)
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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 milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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.
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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
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Primary end point(s): -Progression-free Survival (PFS)
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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 Outcome(s)
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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.
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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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Secondary ID(s)
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CC-5013-DLC-002
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2013-004054-21-ES
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Source(s) of Monetary Support
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Celgene Corporation
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Ethics review
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Status: Approved
Approval date: 19/05/2015
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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