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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30 April 2018 |
Main ID: |
EUCTR2012-000669-19-BE |
Date of registration:
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26/09/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study comparing efficacy of subcutaneous (SC) rituximab and intravenous (IV) rituximab both in combination with CHOP (R-CHOP) in previously untreated patients with CD20 positive diffuse large B-cell lymphoma (DLBCL).
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Scientific title:
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A COMPARATIVE, RANDOMIZED, PARALLEL-GROUP, MULTI-CENTRE, PHASE IIIB STUDY TO INVESTIGATE THE EFFICACY OF SUBCUTANEOUS (SC) RITUXIMAB VERSUS INTRAVENOUS (IV) RITUXIMAB BOTH IN COMBINATION WITH CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL). |
Date of first enrolment:
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25/10/2012 |
Target sample size:
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600 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000669-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
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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Algeria
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Argentina
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Belgium
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Brazil
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Bulgaria
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Canada
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Colombia
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Finland
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France
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Greece
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India
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Ireland
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Israel
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Italy
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Netherlands
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Peru
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Poland
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Portugal
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Russian Federation
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Saudi Arabia
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Serbia
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South Africa
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Spain
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Thailand
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Turkey
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Ukraine
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United Kingdom
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Venezuela, Bolivarian Republic of
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Age = 18 and = 80 years at time of study inclusion
• Histologically confirmed, previously untreated CD20-positive DLBCL according to the WHO classification system
• Patients with an IPI score of 1-5 or IPI score of 0 with bulky disease, defined as one lesion = 7.5 cm
• At least one bi-dimensionally measurable lesion defined as = 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
• Adequate hematologic function
• Eastern Cooperative Oncology Group (ECOG) performance status = 2. 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 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria: • Primary or secondary central nervous system lymphoma, blastic variant of mantle cell lymphoma, or histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
• Transformed lymphoma or follicular lymphoma IIIB
• Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
• History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
• Inadequate renal or hepatic function
• Known human immunodeficiency virus (HIV) infection or HIV seropositive status
• Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
• Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
• Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
• Pregnant or lactating women
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] - Blood and lymphatic diseases [C15]
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Adult patients aged 18-80 years with previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) MedDRA version: 16.1
Level: PT
Classification code 10012818
Term: Diffuse large B-cell lymphoma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Name: rituximab/rHuPH20 SC Product Code: RO0452294/F04 Pharmaceutical Form: Solution for injection INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: RO0452294 Other descriptive name: rituximab/rHuPH20 SC Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120-
Trade Name: MabThera® Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: RO0452294 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-
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Primary Outcome(s)
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Secondary Objective: • To compare patient satisfaction with rituximab administration (SC versus IV) in patients with DLBCL • To evaluate event-free survival, disease-free survival, progression-free survival and overall survival from randomisation (at least 24 months of follow-up) • To evaluate the safety of rituximab (SC versus IV) in patients with DLBCL.
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Primary end point(s): The primary endpoint of CR/CRu (measured from the day of first rituximab induction dose) will be based on the Investigator’s assessment, completed according to the International Working Group response criteria (Cheson et al. 1999) at the end of induction treatment.
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Main Objective: To estimate the efficacy in each treatment arm, as measured by complete response (CR) rate 4?8 weeks after the end of treatment.
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Timepoint(s) of evaluation of this end point: The primary analysis of response rate will take place when all patients have completed their induction treatment.
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Secondary Outcome(s)
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Secondary end point(s): Event-free survival, disease-free survival, progression-free survival and overall survival (EFS, DFS, PFS and OS), patient reported outcomes, administration times and a summary of safety data.
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Timepoint(s) of evaluation of this end point: A preliminary analysis will be performed when all patients have completed their induction treatment.
The final analysis of secondary efficacy endpoints (EFS, DFS, PFS and OS) will be provided when the last patient has completed at least 24 months of follow-up after the end of induction treatment, or when one of the following has been documented for all randomized patients: disease recurrence, withdrawal from the study, loss to follow up or death, whichever occurs first.
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Secondary ID(s)
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MO28107
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NCT01649856
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2012-000669-19-ES
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Source(s) of Monetary Support
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F. Hoffmann-La Roche Ltd
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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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