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).

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2012-000669-19-IT
• Date of registration: 31/08/2012
• Prospective Registration: No
• Primary sponsor: F. HOFFMANN - LA ROCHE LTD.
• Public title: 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).
• Scientific title: 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: 11/07/2012
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000669-19
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Algeria, Argentina, Belgium, Brazil, Bulgaria, Canada, Colombia, Finland, France, Greece, India, Ireland, Israel, Italy, Netherlands, Peru, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, Bolivarian Republic of

Contacts

• Name: Head of Clin. Ops Italy
• Affiliation: Roche S.p.A.

• Name: Head of Clin. Ops Italy
• Affiliation: Roche S.p.A.

Key inclusion & exclusion criteria

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 • 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: 0
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:
• Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma • Presence or history of CNS disease • History of malignancy other than follicular NHL which could affect compliance with protocol or interpretation of results • Recent major surgery (within 4 weeks prior to screening, excluding lymph node biopsy).


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

Health Condition(s) or Problem(s) studied

Adult patients aged 18-80 years with previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)
MedDRA version: 15.1 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Trade Name: MabThera
Pharmaceutical Form: Concentrate 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-

Primary Outcome(s)

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.

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

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.

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.

Secondary Outcome(s)

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.

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.

Secondary ID(s)

2012-000669-19-ES

MO28107

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date: 11/07/2012
Contact:

Results

• Results available: Yes
• Date Posted: 09/04/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-000669-19/results