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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01724021




Registration number
NCT01724021
Ethics application status
Date submitted
5/11/2012
Date registered
9/11/2012
Date last updated
23/01/2018

Titles & IDs
Public title
A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a
Scientific title
A Randomized, Open-label, Mutli-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
Secondary ID [1] 0 0
2012-003230-17
Secondary ID [2] 0 0
MO28457
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma, 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 - Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Treatment: Drugs - Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab

Experimental: Arm A - Participants in Arm A received one cycle of rituximab 375 mg/m\^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m\^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.

Experimental: Arm B - Participants in Arm B received four cycles of rituximab 375 mg/m\^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.


Treatment: Drugs: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy

Treatment: Drugs: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy

Treatment: Drugs: Bendamustine
Standard chemotherapy

Treatment: Drugs: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4

Treatment: Drugs: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4

Treatment: Drugs: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8

Treatment: Drugs: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Timepoint [1] 0 0
Cycle 6 (Up to 24 weeks)
Primary outcome [2] 0 0
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Timepoint [2] 0 0
Cycle 8 (Up to 32 weeks)
Secondary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs)
Timepoint [1] 0 0
Randomization of first participant to clinical cutoff date (Up to 4 years)
Secondary outcome [2] 0 0
Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Timepoint [2] 0 0
Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Secondary outcome [3] 0 0
Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
Timepoint [3] 0 0
During Cycle 4, 8 of treatment (Up to 32 weeks)
Secondary outcome [4] 0 0
Rituximab Administration Satisfaction Questionnaire (RASQ) Score
Timepoint [4] 0 0
During Cycle 4, 8 of treatment (Up to 32 weeks)
Secondary outcome [5] 0 0
Complete Response (CR) Rate
Timepoint [5] 0 0
28 days (± 3 days) after Day 1 of the last dose of induction treatment
Secondary outcome [6] 0 0
Event-free Survival (EFS)
Timepoint [6] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [7] 0 0
Disease-free Survival (DFS)
Timepoint [7] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [8] 0 0
Progression-free Survival (PFS)
Timepoint [8] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [10] 0 0
Percentage of Participants With Anti-Rituximab Antibodies Over Time
Timepoint [10] 0 0
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Secondary outcome [11] 0 0
Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
Timepoint [11] 0 0
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Secondary outcome [12] 0 0
Summary of Observed Serum Rituximab Concentration
Timepoint [12] 0 0
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

Eligibility
Key inclusion criteria
* Adult participants , >/= 18 and </= 80 years of age
* Histologically confirmed, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3a, according to World Health Organization (WHO) classification
* An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion >/= 7.5 cm, or Follicular Lymphoma International Prognostic Index (FLIPI; low, intermediate or high risk)
* At least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on CT scan
* Eastern Cooperative Oncology Group (ECOG) performance status </= 3
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Transformed lymphoma or follicular lymphoma IIIB
* Primary central nervous system (CNS) lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
* History of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for >/= 5 years prior to enrolment; participants 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
* Prior therapy for DLBCL or NHL, with the exception of nodal biopsy or local irradiation
* Prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for CNS prophylaxis in DLBCL) or rituximab for another condition, or prior use of an anti-CD20 drug
* Prior use of monoclonal antibody within 3 months prior to randomization
* Chemotherapy or other investigational therapy within 28 days prior to randomization
* Ongoing corticosteroid use > 30 mg/day prednisolone or equivalent
* Inadequate renal. hematologic or hepatic function
* Active and/or severe infection or any major episode of infection within 4 weeks prior to randomization
* Active hepatitis B virus or active hepatitis C virus infection
* History of human immunodeficiency (HIV) seropositive status
* A positive pregnancy test in women of childbearing potential
* Life expectancy of less than 6 months

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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
743
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Randwick
Recruitment hospital [5] 0 0
- Brisbane
Recruitment hospital [6] 0 0
- Adelaide
Recruitment hospital [7] 0 0
- Hobart
Recruitment hospital [8] 0 0
- Geelong
Recruitment hospital [9] 0 0
- Malvern
Recruitment hospital [10] 0 0
- Melbourne
Recruitment hospital [11] 0 0
- Wodonga
Recruitment hospital [12] 0 0
- Nedlands
Recruitment hospital [13] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
4101 - Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment postcode(s) [11] 0 0
3690 - Wodonga
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Corrientes
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fé
Country [4] 0 0
Austria
State/province [4] 0 0
Krems
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Steyr
Country [8] 0 0
Austria
State/province [8] 0 0
Wien
Country [9] 0 0
Brazil
State/province [9] 0 0
MG
Country [10] 0 0
Brazil
State/province [10] 0 0
PE
Country [11] 0 0
Brazil
State/province [11] 0 0
PR
Country [12] 0 0
Brazil
State/province [12] 0 0
RS
Country [13] 0 0
Brazil
State/province [13] 0 0
SP
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Santiago
Country [18] 0 0
Chile
State/province [18] 0 0
Viña del Mar
Country [19] 0 0
Colombia
State/province [19] 0 0
Monteria
Country [20] 0 0
Croatia
State/province [20] 0 0
Osijek
Country [21] 0 0
Denmark
State/province [21] 0 0
Aalborg
Country [22] 0 0
Denmark
State/province [22] 0 0
Holstebro
Country [23] 0 0
Dominican Republic
State/province [23] 0 0
Santiago de los Caballeros
Country [24] 0 0
Egypt
State/province [24] 0 0
Alexandria
Country [25] 0 0
Egypt
State/province [25] 0 0
Cairo
Country [26] 0 0
El Salvador
State/province [26] 0 0
San Salvador
Country [27] 0 0
Germany
State/province [27] 0 0
Aschaffenburg
Country [28] 0 0
Germany
State/province [28] 0 0
Augsburg
Country [29] 0 0
Germany
State/province [29] 0 0
Bamberg
Country [30] 0 0
Germany
State/province [30] 0 0
Bayreuth
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Bielefeld
Country [33] 0 0
Germany
State/province [33] 0 0
Bochum
Country [34] 0 0
Germany
State/province [34] 0 0
Bonn
Country [35] 0 0
Germany
State/province [35] 0 0
Bottrop
Country [36] 0 0
Germany
State/province [36] 0 0
Brandenburg
Country [37] 0 0
Germany
State/province [37] 0 0
Bremen
Country [38] 0 0
Germany
State/province [38] 0 0
Bremerhaven
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Germany
State/province [39] 0 0
Coesfeld
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Germany
State/province [40] 0 0
Darmstadt
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Germany
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Dresden
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Germany
State/province [42] 0 0
Düsseldorf
Country [43] 0 0
Germany
State/province [43] 0 0
Eisenach
Country [44] 0 0
Germany
State/province [44] 0 0
Essen
Country [45] 0 0
Germany
State/province [45] 0 0
Frankfurt an der Oder
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
Country [47] 0 0
Germany
State/province [47] 0 0
Freiburg
Country [48] 0 0
Germany
State/province [48] 0 0
Fürth
Country [49] 0 0
Germany
State/province [49] 0 0
Georgsmarienhütte
Country [50] 0 0
Germany
State/province [50] 0 0
Giessen
Country [51] 0 0
Germany
State/province [51] 0 0
Goslar
Country [52] 0 0
Germany
State/province [52] 0 0
Gütersloh
Country [53] 0 0
Germany
State/province [53] 0 0
Halle
Country [54] 0 0
Germany
State/province [54] 0 0
Hamburg
Country [55] 0 0
Germany
State/province [55] 0 0
Hamm
Country [56] 0 0
Germany
State/province [56] 0 0
Hanau
Country [57] 0 0
Germany
State/province [57] 0 0
Hannover
Country [58] 0 0
Germany
State/province [58] 0 0
Herford
Country [59] 0 0
Germany
State/province [59] 0 0
Jena
Country [60] 0 0
Germany
State/province [60] 0 0
Kaiserslautern
Country [61] 0 0
Germany
State/province [61] 0 0
Kassel
Country [62] 0 0
Germany
State/province [62] 0 0
Köln
Country [63] 0 0
Germany
State/province [63] 0 0
Leer
Country [64] 0 0
Germany
State/province [64] 0 0
Leipzig
Country [65] 0 0
Germany
State/province [65] 0 0
Limburg
Country [66] 0 0
Germany
State/province [66] 0 0
Lübeck
Country [67] 0 0
Germany
State/province [67] 0 0
Magdeburg
Country [68] 0 0
Germany
State/province [68] 0 0
Mainz
Country [69] 0 0
Germany
State/province [69] 0 0
Mannheim
Country [70] 0 0
Germany
State/province [70] 0 0
Marburg
Country [71] 0 0
Germany
State/province [71] 0 0
Mayen
Country [72] 0 0
Germany
State/province [72] 0 0
Moers
Country [73] 0 0
Germany
State/province [73] 0 0
Mutlangen
Country [74] 0 0
Germany
State/province [74] 0 0
Mönchengladbach
Country [75] 0 0
Germany
State/province [75] 0 0
Mülheim
Country [76] 0 0
Germany
State/province [76] 0 0
München
Country [77] 0 0
Germany
State/province [77] 0 0
Münster
Country [78] 0 0
Germany
State/province [78] 0 0
Neunkirchen/Saar
Country [79] 0 0
Germany
State/province [79] 0 0
Nürnberg
Country [80] 0 0
Germany
State/province [80] 0 0
Oldenburg
Country [81] 0 0
Germany
State/province [81] 0 0
Osnabrueck
Country [82] 0 0
Germany
State/province [82] 0 0
Paderborn
Country [83] 0 0
Germany
State/province [83] 0 0
Pforzheim
Country [84] 0 0
Germany
State/province [84] 0 0
Pinneberg
Country [85] 0 0
Germany
State/province [85] 0 0
Pirna
Country [86] 0 0
Germany
State/province [86] 0 0
Porta Westfalica
Country [87] 0 0
Germany
State/province [87] 0 0
Pößneck
Country [88] 0 0
Germany
State/province [88] 0 0
Ravensburg
Country [89] 0 0
Germany
State/province [89] 0 0
Recklinghausen
Country [90] 0 0
Germany
State/province [90] 0 0
Regensburg
Country [91] 0 0
Germany
State/province [91] 0 0
Rostock
Country [92] 0 0
Germany
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Rötha
Country [93] 0 0
Germany
State/province [93] 0 0
Schweinfurt
Country [94] 0 0
Germany
State/province [94] 0 0
Schwäbisch-Hall
Country [95] 0 0
Germany
State/province [95] 0 0
Siegburg
Country [96] 0 0
Germany
State/province [96] 0 0
Stade
Country [97] 0 0
Germany
State/province [97] 0 0
Stendal
Country [98] 0 0
Germany
State/province [98] 0 0
Stuttgart
Country [99] 0 0
Germany
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Traunstein
Country [100] 0 0
Germany
State/province [100] 0 0
Trier
Country [101] 0 0
Germany
State/province [101] 0 0
Velbert
Country [102] 0 0
Germany
State/province [102] 0 0
Villingen-Schwenningen
Country [103] 0 0
Germany
State/province [103] 0 0
Weilheim
Country [104] 0 0
Germany
State/province [104] 0 0
Wiesbaden
Country [105] 0 0
Germany
State/province [105] 0 0
Wilhelmshaven
Country [106] 0 0
Germany
State/province [106] 0 0
Witten
Country [107] 0 0
Germany
State/province [107] 0 0
Wuerselen
Country [108] 0 0
Germany
State/province [108] 0 0
Zittau
Country [109] 0 0
Germany
State/province [109] 0 0
Zwickau
Country [110] 0 0
Guatemala
State/province [110] 0 0
Guatemala
Country [111] 0 0
Hong Kong
State/province [111] 0 0
Hong Kong
Country [112] 0 0
Hungary
State/province [112] 0 0
Budapest
Country [113] 0 0
Hungary
State/province [113] 0 0
Gyor
Country [114] 0 0
Hungary
State/province [114] 0 0
Gyula
Country [115] 0 0
Hungary
State/province [115] 0 0
Kaposvar
Country [116] 0 0
Hungary
State/province [116] 0 0
Nyíregyháza
Country [117] 0 0
Hungary
State/province [117] 0 0
Szeged
Country [118] 0 0
Hungary
State/province [118] 0 0
Szolnok
Country [119] 0 0
Indonesia
State/province [119] 0 0
Bandung
Country [120] 0 0
Indonesia
State/province [120] 0 0
Jakarta
Country [121] 0 0
Indonesia
State/province [121] 0 0
Jogjakarta
Country [122] 0 0
Indonesia
State/province [122] 0 0
Surabaya
Country [123] 0 0
Italy
State/province [123] 0 0
Calabria
Country [124] 0 0
Italy
State/province [124] 0 0
Emilia-Romagna
Country [125] 0 0
Italy
State/province [125] 0 0
Lazio
Country [126] 0 0
Italy
State/province [126] 0 0
Piemonte
Country [127] 0 0
Italy
State/province [127] 0 0
Puglia
Country [128] 0 0
Italy
State/province [128] 0 0
Sicilia
Country [129] 0 0
Italy
State/province [129] 0 0
Toscana
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Busan
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Daegu
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Seoul
Country [133] 0 0
Malaysia
State/province [133] 0 0
Ampang
Country [134] 0 0
Malaysia
State/province [134] 0 0
Kuala Lumpur
Country [135] 0 0
Malaysia
State/province [135] 0 0
Kuching
Country [136] 0 0
Malaysia
State/province [136] 0 0
Sabah
Country [137] 0 0
Netherlands
State/province [137] 0 0
Amstelveen
Country [138] 0 0
Netherlands
State/province [138] 0 0
Amsterdam
Country [139] 0 0
Netherlands
State/province [139] 0 0
Apeldoorn
Country [140] 0 0
Netherlands
State/province [140] 0 0
Beverwijk
Country [141] 0 0
Netherlands
State/province [141] 0 0
Capelle Aan De Yssel
Country [142] 0 0
Netherlands
State/province [142] 0 0
Delftzijl
Country [143] 0 0
Netherlands
State/province [143] 0 0
Den Haag
Country [144] 0 0
Netherlands
State/province [144] 0 0
Eindhoven
Country [145] 0 0
Netherlands
State/province [145] 0 0
Goes
Country [146] 0 0
Netherlands
State/province [146] 0 0
Leidschendam
Country [147] 0 0
Netherlands
State/province [147] 0 0
Rotterdam
Country [148] 0 0
Netherlands
State/province [148] 0 0
Tilburg
Country [149] 0 0
Netherlands
State/province [149] 0 0
Utrecht
Country [150] 0 0
New Zealand
State/province [150] 0 0
Auckland
Country [151] 0 0
Panama
State/province [151] 0 0
Panama City
Country [152] 0 0
Panama
State/province [152] 0 0
Panama
Country [153] 0 0
Peru
State/province [153] 0 0
Arequipa
Country [154] 0 0
Peru
State/province [154] 0 0
Cusco
Country [155] 0 0
Peru
State/province [155] 0 0
La Victoria, Lima
Country [156] 0 0
Philippines
State/province [156] 0 0
Cebu City
Country [157] 0 0
Philippines
State/province [157] 0 0
Manila
Country [158] 0 0
Philippines
State/province [158] 0 0
Quezon City
Country [159] 0 0
Portugal
State/province [159] 0 0
Lisboa
Country [160] 0 0
Portugal
State/province [160] 0 0
Matosinhos
Country [161] 0 0
Portugal
State/province [161] 0 0
Ponta Delgada
Country [162] 0 0
Portugal
State/province [162] 0 0
Setubal
Country [163] 0 0
Portugal
State/province [163] 0 0
Viseu
Country [164] 0 0
Romania
State/province [164] 0 0
Baia Mare
Country [165] 0 0
Romania
State/province [165] 0 0
Brasov
Country [166] 0 0
Romania
State/province [166] 0 0
Bucharest
Country [167] 0 0
Romania
State/province [167] 0 0
Bucuresti
Country [168] 0 0
Romania
State/province [168] 0 0
Cluj-Napoca
Country [169] 0 0
Romania
State/province [169] 0 0
Craiova
Country [170] 0 0
Romania
State/province [170] 0 0
Iasi
Country [171] 0 0
Romania
State/province [171] 0 0
Sibiu
Country [172] 0 0
Romania
State/province [172] 0 0
Timisoara
Country [173] 0 0
Sweden
State/province [173] 0 0
Falun
Country [174] 0 0
Sweden
State/province [174] 0 0
Göteborg
Country [175] 0 0
Sweden
State/province [175] 0 0
Jönköping
Country [176] 0 0
Sweden
State/province [176] 0 0
Karlstad
Country [177] 0 0
Sweden
State/province [177] 0 0
Sundsvall
Country [178] 0 0
Sweden
State/province [178] 0 0
Västerås
Country [179] 0 0
Taiwan
State/province [179] 0 0
Kaohsung
Country [180] 0 0
Taiwan
State/province [180] 0 0
Taichung
Country [181] 0 0
Taiwan
State/province [181] 0 0
Taipei
Country [182] 0 0
Thailand
State/province [182] 0 0
Bangkok
Country [183] 0 0
Thailand
State/province [183] 0 0
Chiang Mai
Country [184] 0 0
Thailand
State/province [184] 0 0
Khon Kaen
Country [185] 0 0
Turkey
State/province [185] 0 0
Ankara
Country [186] 0 0
Turkey
State/province [186] 0 0
Denizli
Country [187] 0 0
Turkey
State/province [187] 0 0
Erzurum
Country [188] 0 0
Turkey
State/province [188] 0 0
Malatya
Country [189] 0 0
Vietnam
State/province [189] 0 0
Ha Noi
Country [190] 0 0
Vietnam
State/province [190] 0 0
Hochiminh city

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

Ethics approval
Ethics application status

Summary
Brief summary
This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.
Trial website
https://clinicaltrials.gov/study/NCT01724021
Trial related presentations / publications
Rummel M, Kim TM, Aversa F, Brugger W, Capochiani E, Plenteda C, Re F, Trask P, Osborne S, Smith R, Grigg A. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017 Apr 1;28(4):836-842. doi: 10.1093/annonc/mdw685.
Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. doi: 10.2147/PPA.S108489. eCollection 2016.
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/study/NCT01724021