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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 décembre 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

743

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Médicament: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Médicament: Bendamustine
Standard chemotherapy
Autres noms:
  • Treanda
Médicament: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Autres noms:
  • Rituxan
  • MabThera
Médicament: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Autres noms:
  • Rituxan
  • MabThera
Médicament: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Autres noms:
  • Rituxan
  • MabThera
Médicament: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Autres noms:
  • Rituxan
  • MabThera
Expérimental: 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.
Médicament: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Médicament: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Médicament: Bendamustine
Standard chemotherapy
Autres noms:
  • Treanda
Médicament: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Autres noms:
  • Rituxan
  • MabThera
Médicament: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Autres noms:
  • Rituxan
  • MabThera
Médicament: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Autres noms:
  • Rituxan
  • MabThera
Médicament: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Autres noms:
  • Rituxan
  • MabThera

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Treatment Emergent Adverse Events (AEs)
Délai: 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])
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2012

Achèvement primaire (Réel)

1 janvier 2015

Achèvement de l'étude (Réel)

1 janvier 2015

Dates d'inscription aux études

Première soumission

5 novembre 2012

Première soumission répondant aux critères de contrôle qualité

6 novembre 2012

Première publication (Estimation)

9 novembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 janvier 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 décembre 2017

Dernière vérification

1 décembre 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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