A study to assess patient preference after subcutaneous injections of Mabthera versus intravenous infusions Mabthera in previously-untreated patients with diffuse large B-cell lymphoma or follicular non-Hodgkin’s lymphoma.

A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN’S LYMPHOMA GRADES 1, 2 OR 3A

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003230-17-DE

Enrollment

900

Registered

2012-10-08

Start date

2013-02-14

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

The target population will consist of adults with previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the WHO classification system. MedDRA version: 18.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

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 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 and = 80 years at time of randomization 2. Histologically confirmed, previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the WHO classification system 3. An IPI score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion = 7.5 cm, or FLIPI (low, low-intermediate, high-intermediate, high) 4. At least one bi-dimensionally measurable lesion defined as = 1.5 cm in its largest dimension on CT scan 5. Eastern Cooperative Oncology Group (ECOG) performance status = 3. 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 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: 1. Transformed lymphoma or FL IIIB 2. Primary CNS lymphoma, blastic variant of mantle-cell lymphoma, histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL or primary DLBCL of the testis 3. History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for = 5 years prior to enrolment. Note: Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible for the study. 4.Prior therapy for DLBCL or follicular NHL, with the exception of nodal biopsy or local irradiation 5.Prior treatment with cytotoxic drugs (with the exclusion of methotrexate for CNS prophylaxis in DLBCL) or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody 6.Prior use of any monoclonal antibody within 3 months prior to randomization

Design outcomes

Primary

Measure	Time frame
Main Objective: •To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the SC or the IV route of rituximab administration.;Secondary Objective: •To evaluate the safety of rituximab SC •To evaluate and compare the methods of rituximab administration (SC vs. IV) in terms of: - Rituximab administration time defined as the time from start to end of the rituximab SC injection or from start to end of the rituximab IV infusion - Patient-assessed satisfaction and convenience using the Cancer Therapy Satisfaction Questionnaire (CTSQ) and Rituximab Administration Satisfaction Questionnaire (RASQ) •Immunogenicity (anti-rituximab and anti-rHuPH20 antibodies and the associated rituximab concentration level at each anti-rituximab sampling time point). •To evaluate efficacy of rituximab SC in terms of: - complete response rate (CR) including complete response unconfirmed (CRu), 4-8 weeks after the last dose of induction treatment - EFS - DFS - PFS - overall survival (OS). ;Primary end point(s): The proportion of patients who prefer Rituximab SC over Rituximab IV and the corresponding 95% confidence interval will be estimated;Timepoint(s) of evaluation of this end point: The primary analysis of patient preference will take place when all patients have completed induction treatment.	—

Measure

Time frame

Main Objective: •To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the SC or the IV route of rituximab administration.;Secondary Objective: •To evaluate the safety of rituximab SC •To evaluate and compare the methods of rituximab administration (SC vs. IV) in terms of: - Rituximab administration time defined as the time from start to end of the rituximab SC injection or from start to end of the rituximab IV infusion - Patient-assessed satisfaction and convenience using the Cancer Therapy Satisfaction Questionnaire (CTSQ) and Rituximab Administration Satisfaction Questionnaire (RASQ) •Immunogenicity (anti-rituximab and anti-rHuPH20 antibodies and the associated rituximab concentration level at each anti-rituximab sampling time point). •To evaluate efficacy of rituximab SC in terms of: - complete response rate (CR) including complete response unconfirmed (CRu), 4-8 weeks after the last dose of induction treatment - EFS - DFS - PFS - overall survival (OS). ;Primary end point(s): The proportion of patients who prefer Rituximab SC over Rituximab IV and the corresponding 95% confidence interval will be estimated;Timepoint(s) of evaluation of this end point: The primary analysis of patient preference will take place when all patients have completed induction treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Safety will be assessed by AEs, AEs of grade = 3, serious adverse events (SAEs), premature withdrawal from the study and from study medication, laboratory parameters, vital signs and ECOG performance status. Adverse events will be coded in MedDRA. The incidence of AEs and SAEs will be summarized by primary system organ class and preferred term. Laboratory parameters will be presented in shift tables of NCI-CTC grade at baseline against worst grade recorded during each treatment period and overall. Other safety variables will be summarized. The time required for rituximab administration defined as start of rituximab SC injection to end of the injection and start of rituximab IV infusion to the end of the infusion will be summarized. Patient-assessed satisfaction and convenience using RASQ and CTSQ will be summarized and presented by treatment group. Efficacy endpoints: The Complete Response (CR/CRu) rate measured 4-8 weeks after the end of treatment will be summarized. The time-to-event endpoints EFS, DFS, PFS and OS from randomization will be summarized overall and by the two treatment sequence groups using the Kaplan Meier approach. Immunogenicity (anti-rituximab and anti-rHuPH20 antibodies) will be summarized. ;Timepoint(s) of evaluation of this end point: Safety monitoring of data will be performed periodically by the IDMC. The final analysis for the efficacy endpoints (CR/CRu, EFS, DFS, PFS and OS) will be provided when the last patient has completed at least 24 months of follow-up, had disease recurrence, withdrawn from the study, been lost to follow up or died, whichever occurs first	—

Measure

Time frame

Secondary end point(s): Safety will be assessed by AEs, AEs of grade = 3, serious adverse events (SAEs), premature withdrawal from the study and from study medication, laboratory parameters, vital signs and ECOG performance status. Adverse events will be coded in MedDRA. The incidence of AEs and SAEs will be summarized by primary system organ class and preferred term. Laboratory parameters will be presented in shift tables of NCI-CTC grade at baseline against worst grade recorded during each treatment period and overall. Other safety variables will be summarized. The time required for rituximab administration defined as start of rituximab SC injection to end of the injection and start of rituximab IV infusion to the end of the infusion will be summarized. Patient-assessed satisfaction and convenience using RASQ and CTSQ will be summarized and presented by treatment group. Efficacy endpoints: The Complete Response (CR/CRu) rate measured 4-8 weeks after the end of treatment will be summarized. The time-to-event endpoints EFS, DFS, PFS and OS from randomization will be summarized overall and by the two treatment sequence groups using the Kaplan Meier approach. Immunogenicity (anti-rituximab and anti-rHuPH20 antibodies) will be summarized. ;Timepoint(s) of evaluation of this end point: Safety monitoring of data will be performed periodically by the IDMC. The final analysis for the efficacy endpoints (CR/CRu, EFS, DFS, PFS and OS) will be provided when the last patient has completed at least 24 months of follow-up, had disease recurrence, withdrawn from the study, been lost to follow up or died, whichever occurs first

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Countries

Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Panama, Peru, Philippines, Portugal, Romania, Sweden, Switzerland, Taiwan, Thailand, Turkey, Vietnam

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

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