To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route of rituximab administration.
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective for this study is as follows:
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 outcome
The secondary objectives for this study are as follows:
* 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).
The safety objectives for this study are to evaluate the safety of rituximab SC
and rituximab IV in patients with DLBCL or follicular NHL, focusing on SAEs,
Grade * 3 AEs, and Grade * 3 IIRRs according to NCI CTCAE version 4.0.
Background summary
Roche is investigating the subcutaneous injection into the skin of rituximab
(referred to as subcutaneous rituximab) compared to the intravenous rituximab
administration. Compared to iv administration, the sc injection will only take
5 to 7 minutes. This simple SC injection will allow the time of patient stay to
reduce significantly compared to IV administration. This reduction will also
apply to hospital burden associated with IV administration. Additionally, Roche
expects that the subcutaneous administration will increase patient
satisfaction, ease of administration and treatment compliance.
Study objective
To evaluate the proportion of patients indicating an overall preference via a
Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the
intravenous (IV) route of rituximab administration.
Study design
This is a Phase IV, prospective, multi-centre, multinational, open-label
randomized study in approximately 900 adult patients with previously untreated
CD20+ DLBCL or CD20+ follicular NHL. Eligible patients will be randomized to
Treatment Arm A or Arm B (see Figure 1) using a centralized interactive
voice/web response system (IVRS/IWRS) with a 1:1 ratio. Patients will be
stratified (see protocol page 44). Patients randomized to Arm A will receive 1
cycle of rituximab IV then 3 cycles of rituximab SC followed by 4 cycles of
rituximab IV after interim staging. Patients randomized to Arm B will receive 4
cycles of rituximab IV, followed by 4 cycles of rituximab SC after interim
staging. For information regarding Interim staging, see protocol page 44.
Study treatment in both groups will consist of 8 cycles of rituximab
administered in combination with CHOP, CVP or bendamustine, as per standard
local practice. During study treatment, patients will be assessed for safety
and efficacy as detailed in the Schedule of Assessments (see protocol appendix
1).
After induction treatment has been completed after Cycle 8, patients will be
followed every 3 months for the first two years and then every 6 months until
the end of the study, as detailed in the Schedule of Assessments (appendix 1
protocol)
Intervention
Study treatment in both groups will consist of 8 cycles of rituximab
administered in combination with CHOP, CVP or bendamustine, as per standard
local practice.
CHOP: cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone.
CVP: cyclophosphamide, oncovine (vincristine), prednisone
Arm A:
Patients randomized to Arm A will receive 1 cycle of rituximab IV then 3 cycles
of rituximab SC followed by 4 cycles of rituximab IV after interim staging.
Arm B:
Patients randomized to Arm B will receive 4 cycles of rituximab IV, followed by
4 cycles of rituximab SC after interim staging.
Rituximab SC formulation: 11.7 ml - 1400 mg (independent of the BSA)
Rituximab IV: 375 mg/mE2 BSA (10 mg/ml)
For information regarding Interim staging, see protocol page 44.
Study burden and risks
See secties E4, E6 and E9
Beneluxlaan 2a
Woerden 3446 GR
NL
Beneluxlaan 2a
Woerden 3446 GR
NL
Listed location countries
Age
Inclusion criteria
1. Signed, written Informed consent form;2. Age * 18 and * 80 years at time of randomization ;3. Histologically confirmed, previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the WHO classification system;4. 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) ;5. At least one bi-dimensionally measurable lesion defined as * 1.5 cm in its largest dimension on CT scan;6. Eastern Cooperative Oncology Group (ECOG) performance status * 3.
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 ;See for all exclusion criteria: protocol section 4.1.2, page 51-52.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003230-17-NL |
| Other | Het onderzoek is onder het EudraCT nummer terug te vinden op www.rochetrials.com |
| CCMO | NL42241.060.12 |