이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2017년 12월 19일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

743

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
의약품: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
의약품: Bendamustine
Standard chemotherapy
다른 이름들:
  • 트레안다
의약품: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
다른 이름들:
  • 리툭산
  • 맙테라
의약품: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
다른 이름들:
  • 리툭산
  • 맙테라
의약품: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
다른 이름들:
  • 리툭산
  • 맙테라
의약품: Rituximab
1400 mg SC, Day 1 Cycles 5-8
다른 이름들:
  • 리툭산
  • 맙테라
실험적: 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.
의약품: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy
의약품: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy
의약품: Bendamustine
Standard chemotherapy
다른 이름들:
  • 트레안다
의약품: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
다른 이름들:
  • 리툭산
  • 맙테라
의약품: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4
다른 이름들:
  • 리툭산
  • 맙테라
의약품: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
다른 이름들:
  • 리툭산
  • 맙테라
의약품: Rituximab
1400 mg SC, Day 1 Cycles 5-8
다른 이름들:
  • 리툭산
  • 맙테라

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment Emergent Adverse Events (AEs)
기간: 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])
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)

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스폰서

Hoffmann-La Roche

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 12월 1일

기본 완료 (실제)

2015년 1월 1일

연구 완료 (실제)

2015년 1월 1일

연구 등록 날짜

최초 제출

2012년 11월 5일

QC 기준을 충족하는 최초 제출

2012년 11월 6일

처음 게시됨 (추정)

2012년 11월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 1월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 12월 19일

마지막으로 확인됨

2017년 12월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

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

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