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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. Dezember 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

743

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Arzneimittel: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Arzneimittel: Bendamustine
Standard chemotherapy
Andere Namen:
  • Treanda
Arzneimittel: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Andere Namen:
  • Rituxan
  • MabThera
Arzneimittel: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Andere Namen:
  • Rituxan
  • MabThera
Arzneimittel: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Andere Namen:
  • Rituxan
  • MabThera
Arzneimittel: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Andere Namen:
  • Rituxan
  • MabThera
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.
Arzneimittel: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Arzneimittel: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Arzneimittel: Bendamustine
Standard chemotherapy
Andere Namen:
  • Treanda
Arzneimittel: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Andere Namen:
  • Rituxan
  • MabThera
Arzneimittel: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Andere Namen:
  • Rituxan
  • MabThera
Arzneimittel: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Andere Namen:
  • Rituxan
  • MabThera
Arzneimittel: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Andere Namen:
  • Rituxan
  • MabThera

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment Emergent Adverse Events (AEs)
Zeitfenster: 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])
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2012

Primärer Abschluss (Tatsächlich)

1. Januar 2015

Studienabschluss (Tatsächlich)

1. Januar 2015

Studienanmeldedaten

Zuerst eingereicht

5. November 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. November 2012

Zuerst gepostet (Schätzen)

9. November 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Januar 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Dezember 2017

Zuletzt verifiziert

1. Dezember 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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