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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

19 december 2017 bijgewerkt door: Hoffmann-La Roche

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

743

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, 1425
      • Corrientes, Argentinië, 3400
      • Santa Fé, Argentinië, 3000
  • Australië
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australië, 2605
    • New South Wales
      • Camperdown, New South Wales, Australië, 2050
      • Liverpool, New South Wales, Australië, 2170
      • Randwick, New South Wales, Australië, 2031
    • Queensland
      • Brisbane, Queensland, Australië, 4101
    • South Australia
      • Adelaide, South Australia, Australië, 5000
    • Tasmania
      • Hobart, Tasmania, Australië, 7000
    • Victoria
      • Geelong, Victoria, Australië, 3220
      • Malvern, Victoria, Australië, 3144
      • Melbourne, Victoria, Australië, 3084
      • Wodonga, Victoria, Australië, 3690
    • Western Australia
      • Nedlands, Western Australia, Australië, 6009
      • Perth, Western Australia, Australië, 6000
  • Brazilië
    • MG
      • Belo Horizonte, MG, Brazilië, 30150-320
      • Juiz de Fora, MG, Brazilië, 36010-510
      • Varginha, MG, Brazilië, 37062-770
    • PE
      • Recife, PE, Brazilië, 50070-550
    • PR
      • Curitiba, PR, Brazilië, 81520-060
      • Londrina, PR, Brazilië, 86050-190
    • RS
      • Caxias do Sul, RS, Brazilië, 95070-560
      • Novo Hamburgo, RS, Brazilië, 93510-250
      • Santa Maria, RS, Brazilië, 97015-373
    • SP
      • Santo Andre, SP, Brazilië, 09060-650
      • Sao Jose do Rio Preto, SP, Brazilië, 15090-000
  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 2X6
      • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Victoria, British Columbia, Canada, V8R 6V5
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
  • Chili
      • Santiago, Chili, 8380000
      • Santiago, Chili, 8420383
      • Viña del Mar, Chili, 2520612
  • Colombia
      • Monteria, Colombia
  • Denemarken
      • Aalborg, Denemarken, 9000
      • Holstebro, Denemarken, 7500
  • Dominicaanse Republiek
      • Santiago de los Caballeros, Dominicaanse Republiek, 51000
  • Duitsland
      • Aschaffenburg, Duitsland, 63739
      • Augsburg, Duitsland, 86150
      • Bamberg, Duitsland, 96049
      • Bayreuth, Duitsland, 95445
      • Berlin, Duitsland, 10967
      • Berlin, Duitsland, 13581
      • Berlin, Duitsland, 12351
      • Berlin, Duitsland, 10559
      • Bielefeld, Duitsland, 33604
      • Bielefeld, Duitsland, 33611
      • Bochum, Duitsland, 44791
      • Bochum, Duitsland, 44787
      • Bonn, Duitsland, 53127
      • Bottrop, Duitsland, 46236
      • Brandenburg, Duitsland, 14770
      • Bremen, Duitsland, 28177
      • Bremerhaven, Duitsland, 27568
      • Coesfeld, Duitsland, 48653
      • Darmstadt, Duitsland, 64283
      • Darmstadt, Duitsland, 64295
      • Dresden, Duitsland, 01307
      • Dresden, Duitsland, 01127
      • Düsseldorf, Duitsland, 40225
      • Eisenach, Duitsland, 99817
      • Essen, Duitsland, 45122
      • Essen, Duitsland, 45239
      • Frankfurt, Duitsland, 60389
      • Frankfurt, Duitsland, 60488
      • Frankfurt, Duitsland, 60596
      • Frankfurt an der Oder, Duitsland, 15236
      • Freiburg, Duitsland, 79110
      • Fürth, Duitsland, 90766
      • Georgsmarienhütte, Duitsland, 49124
      • Giessen, Duitsland
      • Giessen, Duitsland, 35392
      • Goslar, Duitsland, 38642
      • Gütersloh, Duitsland, 33332
      • Halle, Duitsland, 06110
      • Hamburg, Duitsland, 22081
      • Hamburg, Duitsland, 20246
      • Hamburg, Duitsland, 22457
      • Hamm, Duitsland, 59063
      • Hamm, Duitsland, 59071
      • Hanau, Duitsland, 63450
      • Hannover, Duitsland, 30625
      • Hannover, Duitsland, 30171
      • Herford, Duitsland, 32049
      • Jena, Duitsland, 07747
      • Kaiserslautern, Duitsland, 67655
      • Kassel, Duitsland, 34125
      • Köln, Duitsland, 50677
      • Leer, Duitsland, 26789
      • Leipzig, Duitsland, 04289
      • Limburg, Duitsland, 65549
      • Lübeck, Duitsland, 23562
      • Magdeburg, Duitsland, 39104
      • Mainz, Duitsland, 55122
      • Mannheim, Duitsland, 68161
      • Marburg, Duitsland, 35037
      • Mayen, Duitsland, 56727
      • Moers, Duitsland, 47441
      • Mutlangen, Duitsland, 73557
      • Mönchengladbach, Duitsland, 41239
      • Mülheim, Duitsland, 45468
      • München, Duitsland, 80804
      • Münster, Duitsland, 48149
      • Neunkirchen/Saar, Duitsland, 66538
      • Nürnberg, Duitsland, 90449
      • Oldenburg, Duitsland, 26121
      • Osnabrueck, Duitsland, 49076
      • Paderborn, Duitsland, 33098
      • Pforzheim, Duitsland, 75179
      • Pinneberg, Duitsland, 25421
      • Pirna, Duitsland, 01796
      • Porta Westfalica, Duitsland, 32457
      • Pößneck, Duitsland, 07381
      • Ravensburg, Duitsland, 88212
      • Recklinghausen, Duitsland, 45657
      • Regensburg, Duitsland, 93053
      • Rostock, Duitsland, 18059
      • Rostock, Duitsland, 18057
      • Rostock, Duitsland, 18055
      • Rostock, Duitsland, 18107
      • Rötha, Duitsland, 04571
      • Schweinfurt, Duitsland, 97422
      • Schwäbisch-Hall, Duitsland, 74523
      • Siegburg, Duitsland, 53721
      • Stade, Duitsland, 21680
      • Stendal, Duitsland, 39576
      • Stuttgart, Duitsland, 70173
      • Traunstein, Duitsland, 83278
      • Trier, Duitsland, 54290
      • Velbert, Duitsland, 42551
      • Villingen-Schwenningen, Duitsland, 78052
      • Weilheim, Duitsland, 82362
      • Wiesbaden, Duitsland, 65191
      • Wilhelmshaven, Duitsland, 26382
      • Witten, Duitsland, 58452
      • Wuerselen, Duitsland, 52146
      • Zittau, Duitsland, 02763
      • Zwickau, Duitsland, 08060
  • Egypte
      • Alexandria, Egypte, 11737
      • Cairo, Egypte, 11562
  • El Salvador
      • San Salvador, El Salvador, 1101
  • Filippijnen
      • Cebu City, Filippijnen, 6000
      • Manila, Filippijnen, 1000
      • Manila, Filippijnen, 1003
      • Quezon City, Filippijnen, 1100
  • Guatemala
      • Guatemala, Guatemala, 01010
      • Guatemala, Guatemala, 01-010
  • Hongarije
      • Budapest, Hongarije, 1097
      • Gyor, Hongarije, 9024
      • Gyula, Hongarije, 5700
      • Kaposvar, Hongarije, 7400
      • Nyíregyháza, Hongarije, 4400
      • Szeged, Hongarije, 6720
      • Szolnok, Hongarije, 5004
  • Hongkong
      • Hong Kong, Hongkong
      • Hong Kong, Hongkong, 852
  • Indonesië
      • Bandung, Indonesië, 40161
      • Jakarta, Indonesië, 11420
      • Jogjakarta, Indonesië, 55284
      • Surabaya, Indonesië, 60111
  • Italië
    • Calabria
      • Catanzaro, Calabria, Italië, 88100
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italië, 44100
      • Parma, Emilia-Romagna, Italië, 43126
      • Piacenza, Emilia-Romagna, Italië, 29121
    • Lazio
      • Roma, Lazio, Italië, 00133
    • Piemonte
      • Candiolo, Piemonte, Italië, 10060
      • Cuneo, Piemonte, Italië, 12100
    • Puglia
      • Brindisi, Puglia, Italië, 72100
      • Lecce, Puglia, Italië, 73100
    • Sicilia
      • Palermo, Sicilia, Italië, 90146
    • Toscana
      • Lido Di Camaiore, Toscana, Italië, 55041
      • Livorno, Toscana, Italië, 57124
  • Kalkoen
      • Ankara, Kalkoen, 06100
      • Ankara, Kalkoen, 06200
      • Denizli, Kalkoen, 20070
      • Erzurum, Kalkoen, 25050
      • Malatya, Kalkoen, 44280
  • Korea, republiek van
      • Busan, Korea, republiek van, 602-739
      • Daegu, Korea, republiek van, 41944
      • Seoul, Korea, republiek van, 03080
      • Seoul, Korea, republiek van, 06591
  • Kroatië
      • Osijek, Kroatië, 31000
  • Maleisië
      • Ampang, Maleisië, 68000
      • Kuala Lumpur, Maleisië, 56000
      • Kuching, Maleisië, 93586
      • Sabah, Maleisië, 88586
  • Nederland
      • Amstelveen, Nederland, 1186 AH
      • Amsterdam, Nederland, 1091 AC
      • Apeldoorn, Nederland, 7334 DZ
      • Beverwijk, Nederland, 1942 LE
      • Capelle Aan De Yssel, Nederland, 2906 ZC
      • Delftzijl, Nederland, 9934 JD
      • Den Haag, Nederland, 2512 VA
      • Den Haag, Nederland, 2566 MJ
      • Eindhoven, Nederland, 5623 EJ
      • Goes, Nederland, 4462 RA
      • Leidschendam, Nederland, 2262 BA
      • Rotterdam, Nederland, 3045 PM
      • Tilburg, Nederland, 5022 GC
      • Utrecht, Nederland, 3582 KE
  • Nieuw-Zeeland
      • Auckland, Nieuw-Zeeland
  • Oostenrijk
      • Krems, Oostenrijk, 3500
      • Linz, Oostenrijk, 4020
      • Salzburg, Oostenrijk, 5020
      • Steyr, Oostenrijk, 4400
      • Wien, Oostenrijk, 1140
  • Panama
      • Panama, Panama, 0834-02723
      • Panama, Panama, 080814
      • Panama City, Panama, 0832-00752
  • Peru
      • Arequipa, Peru, 04001
      • Cusco, Peru, 08006
      • La Victoria, Lima, Peru, Lima 13
  • Portugal
      • Lisboa, Portugal, 1449-005
      • Matosinhos, Portugal, 4454-509
      • Ponta Delgada, Portugal, 9500-370
      • Setubal, Portugal, 2910-446
      • Viseu, Portugal, 3504-509
  • Roemenië
      • Baia Mare, Roemenië, 430031
      • Brasov, Roemenië, 500326
      • Brasov, Roemenië, 500152
      • Bucharest, Roemenië, 022328
      • Bucharest, Roemenië, 050098
      • Bucuresti, Roemenië, 030171
      • Cluj-Napoca, Roemenië, 400015
      • Craiova, Roemenië, 200143
      • Iasi, Roemenië, 700483
      • Sibiu, Roemenië, 550245
      • Timisoara, Roemenië, 300239
  • Taiwan
      • Kaohsung, Taiwan, 883
      • Taichung, Taiwan, 40705
      • Taipei, Taiwan, 100
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50200
      • Khon Kaen, Thailand, 40002
  • Vietnam
      • Ha Noi, Vietnam, 70000
      • Hochiminh city, Vietnam, 70000
  • Zweden
      • Falun, Zweden, 79182
      • Göteborg, Zweden, S-413 45
      • Jönköping, Zweden, 551_85
      • Karlstad, Zweden, 65185
      • Sundsvall, Zweden, 85186
      • Västerås, Zweden, SE-71 289

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Geneesmiddel: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Geneesmiddel: Bendamustine
Standard chemotherapy
Andere namen:
  • Treanda
Geneesmiddel: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Andere namen:
  • Rituxan
  • Mab Thera
Geneesmiddel: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Andere namen:
  • Rituxan
  • Mab Thera
Geneesmiddel: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Andere namen:
  • Rituxan
  • Mab Thera
Geneesmiddel: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Andere namen:
  • Rituxan
  • Mab Thera
Experimenteel: 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.
Geneesmiddel: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Geneesmiddel: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Geneesmiddel: Bendamustine
Standard chemotherapy
Andere namen:
  • Treanda
Geneesmiddel: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Andere namen:
  • Rituxan
  • Mab Thera
Geneesmiddel: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Andere namen:
  • Rituxan
  • Mab Thera
Geneesmiddel: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Andere namen:
  • Rituxan
  • Mab Thera
Geneesmiddel: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Andere namen:
  • Rituxan
  • Mab Thera

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Tijdsspanne: Cycle 6 (Up to 24 weeks)
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.
Cycle 6 (Up to 24 weeks)
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Tijdsspanne: Cycle 8 (Up to 32 weeks)
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.
Cycle 8 (Up to 32 weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Treatment Emergent Adverse Events (AEs)
Tijdsspanne: Randomization of first participant to clinical cutoff date (Up to 4 years)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Randomization of first participant to clinical cutoff date (Up to 4 years)
Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Tijdsspanne: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion
Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
Tijdsspanne: During Cycle 4, 8 of treatment (Up to 32 weeks)
CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
During Cycle 4, 8 of treatment (Up to 32 weeks)
Rituximab Administration Satisfaction Questionnaire (RASQ) Score
Tijdsspanne: During Cycle 4, 8 of treatment (Up to 32 weeks)
The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
During Cycle 4, 8 of treatment (Up to 32 weeks)
Complete Response (CR) Rate
Tijdsspanne: 28 days (± 3 days) after Day 1 of the last dose of induction treatment
CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.
28 days (± 3 days) after Day 1 of the last dose of induction treatment
Event-free Survival (EFS)
Tijdsspanne: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD.
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Disease-free Survival (DFS)
Tijdsspanne: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Progression-free Survival (PFS)
Tijdsspanne: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD.
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Overall Survival (OS)
Tijdsspanne: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
OS was defined as the time from randomization to death from any cause.
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Percentage of Participants With Anti-Rituximab Antibodies Over Time
Tijdsspanne: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
Tijdsspanne: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Summary of Observed Serum Rituximab Concentration
Tijdsspanne: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2012

Primaire voltooiing (Werkelijk)

1 januari 2015

Studie voltooiing (Werkelijk)

1 januari 2015

Studieregistratiedata

Eerst ingediend

5 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2012

Eerst geplaatst (Schatting)

9 november 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 januari 2018

Laatste update ingediend die voldeed aan QC-criteria

19 december 2017

Laatst geverifieerd

1 december 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MO28457
  • 2012-003230-17 (EudraCT-nummer)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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