A study to compare subcutaneous MabThera (rituximab) maintenance therapy continued until progression with observation in relapsed/refractory NHL patients who have completed and responded to MabThera containing induction/maintenance therapy.

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2010-023407-95-ES
• Date of registration: 11/11/2011
• Prospective Registration: No
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A study to compare subcutaneous MabThera (rituximab) maintenance therapy continued until progression with observation in relapsed/refractory NHL patients who have completed and responded to MabThera containing induction/maintenance therapy.
• Scientific title: A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin's lymphoma who completed and responded to a 6-month rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
• Date of first enrolment: 21/09/2011
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023407-95
• 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: no; Placebo: no; Other: yes; Other specify the comparator: MabThera i.v; 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

Albania, Argentina, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Italy, Lithuania, Norway, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Age ? 18 years.
- Histologically confirmed, CD20+ follicular NHL Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to the WHO classification system, other not further classified low malignant lymphoma by immunohistochemistry.
- Patients must have received and must have relapsed or been refractory to one or more lines of adequate induction therapy prior to enrolment, including at least one line consisting of immunotherapy and/or chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status < or = 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 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion criteria:
- Transformation to high-grade lymphoma.
- Patients with aggressive lymphoma (e.g. mantle cell lymphoma).
- Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis).
- Other malignancy within 5 years prior to enrolment, with the following exceptions (as long as curatively treated): carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or basal cell skin cancer.
Cervical carcinoma stage 1B or less, breast cancer in situ, or localized prostate cancer stage T1c or less may be considered, provided that the patient was treated with curative intent and has been relapse- and metastasis-free for at least 2 years prior to enrolment.
- Inadequate hepatic or renal function prior to the first rituximab
induction dose.
- Known human immunodeficiency virus (HIV) infection.


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

Health Condition(s) or Problem(s) studied

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

Patients with relapsed or refractory CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma), according to the WHO classification system, or other not further classified low malignant lymphoma by immunohistochemistry.
MedDRA version: 14.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: rituximab/rHuPH20 SC
Product Code: RO0452294/F04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rituximab/rHuPH20 SC
CAS Number: 174722-31-7
Current Sponsor code: RO0452294
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: RO0452294
Other descriptive name: RITUXIMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint of the study is PFSrand. It is defined as the time from day of randomization to maintenance phase II to the first documented disease progression or death, whichever occurs first.

Secondary Objective: To evaluate the efficacy and safety of SC rituximab during Induction,
initial 2-year maintenance (Maintenance I) and randomized treatment
period (Maintenance II). Efficacy will be evaluated in terms of Event-
Free Survival (EFS), Time to Next Lymphoma Treatment (TNLT), Overall
survival (OS), Overall Response Rate (ORR), Partial Response (PR) to
Complete Response (CR) conversion rate, and PFS measured from the
first Induction dose of rituximab (PFSregist). Safety assessments will
include frequency of adverse events (AEs), serious adverse events
(SAEs), and infusion/injection-related reactions (IRRs) and
immunoglobulin (Ig) quantification.

Timepoint(s) of evaluation of this end point: Day 1 every 8 weeks [56 ± 7 days] until PD

Main Objective: To evaluate the efficacy in term of progression-free survival after
randomization (PFSrand) of a subcutaneous (SC) formulation of
rituximab in patients who responded to Induction and initial 2 years
maintenance therapy (Maintenance I), and were randomized to either
prolonged rituximab maintenance until progression (Maintenance II) or
observation.

Secondary Outcome(s)

Secondary end point(s): Progression free survival (PFS) measured from the day of first rituximab Induction dose (PFSregist), Event-free survival (EFS), Time to next lymphoma treatment (TNLT), Overall survival (OS), Overall Response Rate (ORR) and PR to CR conversion rate at the end of Induction and end
of Maintenance I.

Timepoint(s) of evaluation of this end point: Time Frame: Week 24 (cycle 8)

Secondary ID(s)

MO25455

2010-023407-95-GB

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd