Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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 de diciembre de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

743

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Droga: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Droga: Bendamustine
Standard chemotherapy
Otros nombres:
  • Treanda
Droga: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Otros nombres:
  • Rituxan
  • MabThera
Droga: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Otros nombres:
  • Rituxan
  • MabThera
Droga: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Otros nombres:
  • Rituxan
  • MabThera
Droga: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Otros nombres:
  • 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.
Droga: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
Droga: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
Droga: Bendamustine
Standard chemotherapy
Otros nombres:
  • Treanda
Droga: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Otros nombres:
  • Rituxan
  • MabThera
Droga: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
Otros nombres:
  • Rituxan
  • MabThera
Droga: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Otros nombres:
  • Rituxan
  • MabThera
Droga: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Otros nombres:
  • Rituxan
  • MabThera

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Treatment Emergent Adverse Events (AEs)
Periodo de tiempo: 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])
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hoffmann-La Roche

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2012

Finalización primaria (Actual)

1 de enero de 2015

Finalización del estudio (Actual)

1 de enero de 2015

Fechas de registro del estudio

Enviado por primera vez

5 de noviembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

6 de noviembre de 2012

Publicado por primera vez (Estimar)

9 de noviembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de enero de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

19 de diciembre de 2017

Última verificación

1 de diciembre de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir