Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01200758




Registration number
NCT01200758
Ethics application status
Date submitted
10/09/2010
Date registered
14/09/2010
Date last updated
27/11/2018

Titles & IDs
Public title
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
Scientific title
A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
Secondary ID [1] 0 0
2010-021377-36
Secondary ID [2] 0 0
BO22334
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rituximab SC
Treatment: Drugs - Rituximab IV
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone/Prednisolone

Active comparator: Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) - Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

Experimental: Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) - First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.


Treatment: Drugs: Rituximab SC
First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.

Treatment: Drugs: Rituximab IV
Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

Treatment: Drugs: Cyclophosphamide
Eight cycles of cyclophosphamide (750 mg/m\^2 IV) administered every 3 weeks.

Treatment: Drugs: Doxorubicin
Eight cycles of doxorubicin (50 mg/m\^2 IV) administered every 3 weeks.

Treatment: Drugs: Vincristine
Eight cycles of doxorubicin (1.4 mg/m\^2 IV) administered every 3 weeks.

Treatment: Drugs: Prednisone/Prednisolone
Eight cycles of prednisone/prednisolone (100 mg/day or 40 mg/m\^2/day IV/orally) administered Days 1 to 5 of every 21 days cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
Assessment method [1] 0 0
Timepoint [1] 0 0
Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)
Primary outcome [2] 0 0
Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)
Assessment method [2] 0 0
Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (\>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (=) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.
Timepoint [2] 0 0
Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary outcome [1] 0 0
Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Assessment method [1] 0 0
Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in the SPD; PR: =50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.
Timepoint [1] 0 0
Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary outcome [2] 0 0
Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Assessment method [2] 0 0
Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD; PR: =50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Timepoint [2] 0 0
Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary outcome [3] 0 0
Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Assessment method [3] 0 0
Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Timepoint [3] 0 0
Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary outcome [4] 0 0
Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Assessment method [4] 0 0
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Timepoint [4] 0 0
Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary outcome [5] 0 0
Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
Assessment method [5] 0 0
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Timepoint [5] 0 0
Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
Secondary outcome [6] 0 0
Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
Assessment method [6] 0 0
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Timepoint [6] 0 0
Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
Secondary outcome [7] 0 0
Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
Assessment method [7] 0 0
Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Timepoint [7] 0 0
Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
Secondary outcome [8] 0 0
Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
Assessment method [8] 0 0
Disease progression: =50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or =50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
Timepoint [8] 0 0
Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Secondary outcome [9] 0 0
Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
Assessment method [9] 0 0
PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: =50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or =50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
Timepoint [9] 0 0
Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Secondary outcome [10] 0 0
Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL
Assessment method [10] 0 0
Disease progression: =50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or =50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
Timepoint [10] 0 0
Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Secondary outcome [11] 0 0
Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
Assessment method [11] 0 0
Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
Timepoint [11] 0 0
Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
Secondary outcome [12] 0 0
Percentage of Participants Who Died
Assessment method [12] 0 0
Timepoint [12] 0 0
Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
Secondary outcome [13] 0 0
Overall Survival (OS)
Assessment method [13] 0 0
OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.
Timepoint [13] 0 0
Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
Secondary outcome [14] 0 0
Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
Assessment method [14] 0 0
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])
Timepoint [14] 0 0
Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
Secondary outcome [15] 0 0
Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
Assessment method [15] 0 0
Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])
Timepoint [15] 0 0
Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
Secondary outcome [16] 0 0
Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
Assessment method [16] 0 0
Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks \& 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 \& Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 \[up to 32 months\])
Timepoint [16] 0 0
Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)
Secondary outcome [17] 0 0
Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
Assessment method [17] 0 0
Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 \[1 Cy=8 weeks\]; up to data cutoff of 11 Jan 2016 \[up to 6 years\])
Timepoint [17] 0 0
Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)
Secondary outcome [18] 0 0
Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
Assessment method [18] 0 0
Timepoint [18] 0 0
12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])
Secondary outcome [19] 0 0
Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
Assessment method [19] 0 0
Depletion is defined as a cluster of differentiation (CD) 19 value \<80 cells per cubic millimeter (cells/mm\^3).
Timepoint [19] 0 0
Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2
Secondary outcome [20] 0 0
Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
Assessment method [20] 0 0
Depletion is defined as a CD19 value \<80 cells/mm\^3.
Timepoint [20] 0 0
Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])
Secondary outcome [21] 0 0
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
Assessment method [21] 0 0
Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 \[up to 6 years\])
Timepoint [21] 0 0
Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
Secondary outcome [22] 0 0
Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
Assessment method [22] 0 0
Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 \[up to 6 years\])
Timepoint [22] 0 0
Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
Secondary outcome [23] 0 0
Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20
Assessment method [23] 0 0
All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (\<) 1 hr, at least 1 hr but \<2 hrs, at least 2 hrs but \<3 hrs, at least 3 hrs but \<4 hrs, \>/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.
Timepoint [23] 0 0
After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
Secondary outcome [24] 0 0
Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion
Assessment method [24] 0 0
All investigator physicians and nurses involved in this study were asked to complete question i.e. "Which formulation of rituximab (SC or IV) do you think is more convenient?" based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient.
Timepoint [24] 0 0
After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)

Eligibility
Key inclusion criteria
* Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review
* No prior treatment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Grade 3b follicular lymphoma
* Transformation to high-grade lymphoma secondary to follicular lymphoma
* Types of Non-Hodgkin's lymphoma other than follicular lymphoma
* Presence or history of central nervous system (CNS) disease
* Corticoid therapy during the last 4 weeks, except prednisone treatment less than (<) 20 milligrams per day (mg per day)
* Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2017
Sample size
Target
Accrual to date
Final
410
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Gosford Hospital; Cancer Care Services - Gosford
Recruitment hospital [2] 0 0
Wollongong Hospital; Cancer Services - Wollongong
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Gold Coast Hospital; Haematology Department - Southport
Recruitment hospital [5] 0 0
Queen Elizabeth Hospital; Haematology - Woodville South
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Edegem
Country [2] 0 0
Belgium
State/province [2] 0 0
Liège
Country [3] 0 0
Belgium
State/province [3] 0 0
Wilrijk
Country [4] 0 0
Bosnia and Herzegovina
State/province [4] 0 0
Banja Luka
Country [5] 0 0
Bosnia and Herzegovina
State/province [5] 0 0
Sarajevo
Country [6] 0 0
Bosnia and Herzegovina
State/province [6] 0 0
Tuzla
Country [7] 0 0
Brazil
State/province [7] 0 0
MG
Country [8] 0 0
Brazil
State/province [8] 0 0
RS
Country [9] 0 0
Brazil
State/province [9] 0 0
SP
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Pleven
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Plovdiv
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Sofia
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Varna
Country [14] 0 0
Canada
State/province [14] 0 0
Nova Scotia
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Colombia
State/province [16] 0 0
Bogota
Country [17] 0 0
Colombia
State/province [17] 0 0
Cali
Country [18] 0 0
Colombia
State/province [18] 0 0
Medellin-Antioquia
Country [19] 0 0
Colombia
State/province [19] 0 0
Pereira
Country [20] 0 0
Croatia
State/province [20] 0 0
Rijeka
Country [21] 0 0
Croatia
State/province [21] 0 0
Zagreb
Country [22] 0 0
Denmark
State/province [22] 0 0
Herlev
Country [23] 0 0
Denmark
State/province [23] 0 0
København Ø
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense C
Country [25] 0 0
Denmark
State/province [25] 0 0
Roskilde
Country [26] 0 0
Denmark
State/province [26] 0 0
Vejle
Country [27] 0 0
Denmark
State/province [27] 0 0
Århus
Country [28] 0 0
Finland
State/province [28] 0 0
Helsinki
Country [29] 0 0
France
State/province [29] 0 0
Bordeaux
Country [30] 0 0
France
State/province [30] 0 0
Creteil
Country [31] 0 0
France
State/province [31] 0 0
Dijon
Country [32] 0 0
France
State/province [32] 0 0
Le Mans
Country [33] 0 0
France
State/province [33] 0 0
Marseille
Country [34] 0 0
France
State/province [34] 0 0
Montpellier
Country [35] 0 0
France
State/province [35] 0 0
Nantes
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
France
State/province [37] 0 0
Pessac
Country [38] 0 0
France
State/province [38] 0 0
Pierre Benite
Country [39] 0 0
France
State/province [39] 0 0
Poitiers
Country [40] 0 0
France
State/province [40] 0 0
Tours
Country [41] 0 0
Georgia
State/province [41] 0 0
Tbilisi
Country [42] 0 0
Germany
State/province [42] 0 0
Berlin
Country [43] 0 0
Germany
State/province [43] 0 0
Darmstadt
Country [44] 0 0
Germany
State/province [44] 0 0
Dresden
Country [45] 0 0
Germany
State/province [45] 0 0
Frechen
Country [46] 0 0
Germany
State/province [46] 0 0
Giessen
Country [47] 0 0
Germany
State/province [47] 0 0
Greifswald
Country [48] 0 0
Germany
State/province [48] 0 0
Halle
Country [49] 0 0
Germany
State/province [49] 0 0
Hannover
Country [50] 0 0
Germany
State/province [50] 0 0
Karlsruhe
Country [51] 0 0
Germany
State/province [51] 0 0
Kiel
Country [52] 0 0
Germany
State/province [52] 0 0
Koeln
Country [53] 0 0
Germany
State/province [53] 0 0
Magdeburg
Country [54] 0 0
Germany
State/province [54] 0 0
Marburg
Country [55] 0 0
Germany
State/province [55] 0 0
München
Country [56] 0 0
Germany
State/province [56] 0 0
Naunhof
Country [57] 0 0
Germany
State/province [57] 0 0
Olpe
Country [58] 0 0
Germany
State/province [58] 0 0
Recklinghausen
Country [59] 0 0
Germany
State/province [59] 0 0
Saalfeld
Country [60] 0 0
Germany
State/province [60] 0 0
Saarbruecken
Country [61] 0 0
Greece
State/province [61] 0 0
Athens
Country [62] 0 0
Italy
State/province [62] 0 0
Basilicata
Country [63] 0 0
Italy
State/province [63] 0 0
Campania
Country [64] 0 0
Italy
State/province [64] 0 0
Emilia-Romagna
Country [65] 0 0
Italy
State/province [65] 0 0
Lazio
Country [66] 0 0
Italy
State/province [66] 0 0
Liguria
Country [67] 0 0
Italy
State/province [67] 0 0
Lombardia
Country [68] 0 0
Italy
State/province [68] 0 0
Puglia
Country [69] 0 0
Italy
State/province [69] 0 0
Veneto
Country [70] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [70] 0 0
Skopje
Country [71] 0 0
Malaysia
State/province [71] 0 0
FED. Territory OF Kuala Lumpur
Country [72] 0 0
Malaysia
State/province [72] 0 0
Ampang
Country [73] 0 0
Malaysia
State/province [73] 0 0
Sarawak
Country [74] 0 0
Mexico
State/province [74] 0 0
Chihuahua
Country [75] 0 0
Mexico
State/province [75] 0 0
Culiacan
Country [76] 0 0
Mexico
State/province [76] 0 0
Monterrey
Country [77] 0 0
Mexico
State/province [77] 0 0
Queretaro
Country [78] 0 0
New Zealand
State/province [78] 0 0
Christchurch
Country [79] 0 0
New Zealand
State/province [79] 0 0
Palmerston North
Country [80] 0 0
Peru
State/province [80] 0 0
Lima
Country [81] 0 0
Romania
State/province [81] 0 0
Brasov
Country [82] 0 0
Romania
State/province [82] 0 0
Bucharest
Country [83] 0 0
Romania
State/province [83] 0 0
Iasi
Country [84] 0 0
Romania
State/province [84] 0 0
Targu-mures
Country [85] 0 0
Romania
State/province [85] 0 0
Timisoara
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Kazan
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Moscow
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Penza
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Saint-Petersburg
Country [90] 0 0
Russian Federation
State/province [90] 0 0
St Petersburg
Country [91] 0 0
Russian Federation
State/province [91] 0 0
St.Petersburg, Pesochny
Country [92] 0 0
Serbia
State/province [92] 0 0
Belgrade
Country [93] 0 0
Serbia
State/province [93] 0 0
Novi Sad
Country [94] 0 0
Singapore
State/province [94] 0 0
Singapore
Country [95] 0 0
Slovakia
State/province [95] 0 0
Bratislava
Country [96] 0 0
South Africa
State/province [96] 0 0
Bloemfontein
Country [97] 0 0
South Africa
State/province [97] 0 0
Congella
Country [98] 0 0
South Africa
State/province [98] 0 0
Durban
Country [99] 0 0
South Africa
State/province [99] 0 0
Johannesburg
Country [100] 0 0
South Africa
State/province [100] 0 0
Kraaifontein
Country [101] 0 0
Spain
State/province [101] 0 0
Cadiz
Country [102] 0 0
Spain
State/province [102] 0 0
Barcelona
Country [103] 0 0
Spain
State/province [103] 0 0
Madrid
Country [104] 0 0
Spain
State/province [104] 0 0
Murcia
Country [105] 0 0
Spain
State/province [105] 0 0
Salamanca
Country [106] 0 0
Spain
State/province [106] 0 0
Sevilla
Country [107] 0 0
Spain
State/province [107] 0 0
Valencia
Country [108] 0 0
Thailand
State/province [108] 0 0
Bangkok
Country [109] 0 0
Thailand
State/province [109] 0 0
Khon Kaen
Country [110] 0 0
Turkey
State/province [110] 0 0
Adana
Country [111] 0 0
Turkey
State/province [111] 0 0
Istanbul
Country [112] 0 0
Turkey
State/province [112] 0 0
Izmir
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Dundee
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Maidstone
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Plymouth
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Romford
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Southampton
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Wakefield
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01200758