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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This two-stage, multi-center, randomized, controlled, open-label study will investigate the
pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants
with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized
to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400
milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy.
Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will
receive maintenance treatment for a further maximum number of 12 cycles. Maintenance
treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was
designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum
Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3
weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1.
Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with
rituximab IV. The anticipated time on study treatment is 96 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01200758
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01200758