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 dicembre 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Tipo di studio
Interventistico
Iscrizione (Effettivo)
743
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Buenos Aires, Argentina, 1425
-
Corrientes, Argentina, 3400
-
Santa Fé, Argentina, 3000
-
-
-
-
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
-
-
-
-
-
Krems, Austria, 3500
-
Linz, Austria, 4020
-
Salzburg, Austria, 5020
-
Steyr, Austria, 4400
-
Wien, Austria, 1140
-
-
-
-
MG
-
Belo Horizonte, MG, Brasile, 30150-320
-
Juiz de Fora, MG, Brasile, 36010-510
-
Varginha, MG, Brasile, 37062-770
-
-
PE
-
Recife, PE, Brasile, 50070-550
-
-
PR
-
Curitiba, PR, Brasile, 81520-060
-
Londrina, PR, Brasile, 86050-190
-
-
RS
-
Caxias do Sul, RS, Brasile, 95070-560
-
Novo Hamburgo, RS, Brasile, 93510-250
-
Santa Maria, RS, Brasile, 97015-373
-
-
SP
-
Santo Andre, SP, Brasile, 09060-650
-
Sao Jose do Rio Preto, SP, Brasile, 15090-000
-
-
-
-
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
-
-
-
-
-
Santiago, Chile, 8380000
-
Santiago, Chile, 8420383
-
Viña del Mar, Chile, 2520612
-
-
-
-
-
Monteria, Colombia
-
-
-
-
-
Busan, Corea, Repubblica di, 602-739
-
Daegu, Corea, Repubblica di, 41944
-
Seoul, Corea, Repubblica di, 03080
-
Seoul, Corea, Repubblica di, 06591
-
-
-
-
-
Osijek, Croazia, 31000
-
-
-
-
-
Aalborg, Danimarca, 9000
-
Holstebro, Danimarca, 7500
-
-
-
-
-
Alexandria, Egitto, 11737
-
Cairo, Egitto, 11562
-
-
-
-
-
San Salvador, El Salvador, 1101
-
-
-
-
-
Cebu City, Filippine, 6000
-
Manila, Filippine, 1000
-
Manila, Filippine, 1003
-
Quezon City, Filippine, 1100
-
-
-
-
-
Aschaffenburg, Germania, 63739
-
Augsburg, Germania, 86150
-
Bamberg, Germania, 96049
-
Bayreuth, Germania, 95445
-
Berlin, Germania, 10967
-
Berlin, Germania, 13581
-
Berlin, Germania, 12351
-
Berlin, Germania, 10559
-
Bielefeld, Germania, 33604
-
Bielefeld, Germania, 33611
-
Bochum, Germania, 44791
-
Bochum, Germania, 44787
-
Bonn, Germania, 53127
-
Bottrop, Germania, 46236
-
Brandenburg, Germania, 14770
-
Bremen, Germania, 28177
-
Bremerhaven, Germania, 27568
-
Coesfeld, Germania, 48653
-
Darmstadt, Germania, 64283
-
Darmstadt, Germania, 64295
-
Dresden, Germania, 01307
-
Dresden, Germania, 01127
-
Düsseldorf, Germania, 40225
-
Eisenach, Germania, 99817
-
Essen, Germania, 45122
-
Essen, Germania, 45239
-
Frankfurt, Germania, 60389
-
Frankfurt, Germania, 60488
-
Frankfurt, Germania, 60596
-
Frankfurt an der Oder, Germania, 15236
-
Freiburg, Germania, 79110
-
Fürth, Germania, 90766
-
Georgsmarienhütte, Germania, 49124
-
Giessen, Germania
-
Giessen, Germania, 35392
-
Goslar, Germania, 38642
-
Gütersloh, Germania, 33332
-
Halle, Germania, 06110
-
Hamburg, Germania, 22081
-
Hamburg, Germania, 20246
-
Hamburg, Germania, 22457
-
Hamm, Germania, 59063
-
Hamm, Germania, 59071
-
Hanau, Germania, 63450
-
Hannover, Germania, 30625
-
Hannover, Germania, 30171
-
Herford, Germania, 32049
-
Jena, Germania, 07747
-
Kaiserslautern, Germania, 67655
-
Kassel, Germania, 34125
-
Köln, Germania, 50677
-
Leer, Germania, 26789
-
Leipzig, Germania, 04289
-
Limburg, Germania, 65549
-
Lübeck, Germania, 23562
-
Magdeburg, Germania, 39104
-
Mainz, Germania, 55122
-
Mannheim, Germania, 68161
-
Marburg, Germania, 35037
-
Mayen, Germania, 56727
-
Moers, Germania, 47441
-
Mutlangen, Germania, 73557
-
Mönchengladbach, Germania, 41239
-
Mülheim, Germania, 45468
-
München, Germania, 80804
-
Münster, Germania, 48149
-
Neunkirchen/Saar, Germania, 66538
-
Nürnberg, Germania, 90449
-
Oldenburg, Germania, 26121
-
Osnabrueck, Germania, 49076
-
Paderborn, Germania, 33098
-
Pforzheim, Germania, 75179
-
Pinneberg, Germania, 25421
-
Pirna, Germania, 01796
-
Porta Westfalica, Germania, 32457
-
Pößneck, Germania, 07381
-
Ravensburg, Germania, 88212
-
Recklinghausen, Germania, 45657
-
Regensburg, Germania, 93053
-
Rostock, Germania, 18059
-
Rostock, Germania, 18057
-
Rostock, Germania, 18055
-
Rostock, Germania, 18107
-
Rötha, Germania, 04571
-
Schweinfurt, Germania, 97422
-
Schwäbisch-Hall, Germania, 74523
-
Siegburg, Germania, 53721
-
Stade, Germania, 21680
-
Stendal, Germania, 39576
-
Stuttgart, Germania, 70173
-
Traunstein, Germania, 83278
-
Trier, Germania, 54290
-
Velbert, Germania, 42551
-
Villingen-Schwenningen, Germania, 78052
-
Weilheim, Germania, 82362
-
Wiesbaden, Germania, 65191
-
Wilhelmshaven, Germania, 26382
-
Witten, Germania, 58452
-
Wuerselen, Germania, 52146
-
Zittau, Germania, 02763
-
Zwickau, Germania, 08060
-
-
-
-
-
Guatemala, Guatemala, 01010
-
Guatemala, Guatemala, 01-010
-
-
-
-
-
Hong Kong, Hong Kong
-
Hong Kong, Hong Kong, 852
-
-
-
-
-
Bandung, Indonesia, 40161
-
Jakarta, Indonesia, 11420
-
Jogjakarta, Indonesia, 55284
-
Surabaya, Indonesia, 60111
-
-
-
-
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
-
-
-
-
-
Ampang, Malaysia, 68000
-
Kuala Lumpur, Malaysia, 56000
-
Kuching, Malaysia, 93586
-
Sabah, Malaysia, 88586
-
-
-
-
-
Auckland, Nuova Zelanda
-
-
-
-
-
Amstelveen, Olanda, 1186 AH
-
Amsterdam, Olanda, 1091 AC
-
Apeldoorn, Olanda, 7334 DZ
-
Beverwijk, Olanda, 1942 LE
-
Capelle Aan De Yssel, Olanda, 2906 ZC
-
Delftzijl, Olanda, 9934 JD
-
Den Haag, Olanda, 2512 VA
-
Den Haag, Olanda, 2566 MJ
-
Eindhoven, Olanda, 5623 EJ
-
Goes, Olanda, 4462 RA
-
Leidschendam, Olanda, 2262 BA
-
Rotterdam, Olanda, 3045 PM
-
Tilburg, Olanda, 5022 GC
-
Utrecht, Olanda, 3582 KE
-
-
-
-
-
Panama, Panama, 0834-02723
-
Panama, Panama, 080814
-
Panama City, Panama, 0832-00752
-
-
-
-
-
Arequipa, Perù, 04001
-
Cusco, Perù, 08006
-
La Victoria, Lima, Perù, Lima 13
-
-
-
-
-
Lisboa, Portogallo, 1449-005
-
Matosinhos, Portogallo, 4454-509
-
Ponta Delgada, Portogallo, 9500-370
-
Setubal, Portogallo, 2910-446
-
Viseu, Portogallo, 3504-509
-
-
-
-
-
Santiago de los Caballeros, Repubblica Dominicana, 51000
-
-
-
-
-
Baia Mare, Romania, 430031
-
Brasov, Romania, 500326
-
Brasov, Romania, 500152
-
Bucharest, Romania, 022328
-
Bucharest, Romania, 050098
-
Bucuresti, Romania, 030171
-
Cluj-Napoca, Romania, 400015
-
Craiova, Romania, 200143
-
Iasi, Romania, 700483
-
Sibiu, Romania, 550245
-
Timisoara, Romania, 300239
-
-
-
-
-
Falun, Svezia, 79182
-
Göteborg, Svezia, S-413 45
-
Jönköping, Svezia, 551_85
-
Karlstad, Svezia, 65185
-
Sundsvall, Svezia, 85186
-
Västerås, Svezia, SE-71 289
-
-
-
-
-
Ankara, Tacchino, 06100
-
Ankara, Tacchino, 06200
-
Denizli, Tacchino, 20070
-
Erzurum, Tacchino, 25050
-
Malatya, Tacchino, 44280
-
-
-
-
-
Bangkok, Tailandia, 10400
-
Bangkok, Tailandia, 10700
-
Bangkok, Tailandia, 10330
-
Chiang Mai, Tailandia, 50200
-
Khon Kaen, Tailandia, 40002
-
-
-
-
-
Kaohsung, Taiwan, 883
-
Taichung, Taiwan, 40705
-
Taipei, Taiwan, 100
-
-
-
-
-
Budapest, Ungheria, 1097
-
Gyor, Ungheria, 9024
-
Gyula, Ungheria, 5700
-
Kaposvar, Ungheria, 7400
-
Nyíregyháza, Ungheria, 4400
-
Szeged, Ungheria, 6720
-
Szolnok, Ungheria, 5004
-
-
-
-
-
Ha Noi, Vietnam, 70000
-
Hochiminh city, Vietnam, 70000
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Standard chemotherapy
Standard chemotherapy
Standard chemotherapy
Altri nomi:
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Altri nomi:
375 mg/m2 IV, Day 1 Cycles 1-4
Altri nomi:
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Altri nomi:
1400 mg SC, Day 1 Cycles 5-8
Altri nomi:
|
|
Sperimentale: 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.
|
Standard chemotherapy
Standard chemotherapy
Standard chemotherapy
Altri nomi:
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Altri nomi:
375 mg/m2 IV, Day 1 Cycles 1-4
Altri nomi:
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Altri nomi:
1400 mg SC, Day 1 Cycles 5-8
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
Lasso di tempo: 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])
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. doi: 10.2147/PPA.S108489. eCollection 2016.
- Rummel M, Kim TM, Aversa F, Brugger W, Capochiani E, Plenteda C, Re F, Trask P, Osborne S, Smith R, Grigg A. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017 Apr 1;28(4):836-842. doi: 10.1093/annonc/mdw685.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2012
Completamento primario (Effettivo)
1 gennaio 2015
Completamento dello studio (Effettivo)
1 gennaio 2015
Date di iscrizione allo studio
Primo inviato
5 novembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
6 novembre 2012
Primo Inserito (Stima)
9 novembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 gennaio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 dicembre 2017
Ultimo verificato
1 dicembre 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma
- Linfoma, follicolare
- Linfoma, cellule B
- Linfoma, a grandi cellule B, diffuso
- Linfoma non Hodgkin
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti antireumatici
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Agenti neuroprotettivi
- Agenti protettivi
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Agenti antineoplastici, immunologici
- Antibiotici, Antineoplastici
- Prednisolone
- Acetato di metilprednisolone
- Metilprednisolone
- Metilprednisolone emisuccinato
- Prednisolone acetato
- Prednisolone emisuccinato
- Prednisolone fosfato
- Ciclofosfamide
- Bendamustina cloridrato
- Rituximab
- Prednisone
- Doxorubicina
- Doxorubicina liposomiale
- Vincristina
Altri numeri di identificazione dello studio
- MO28457
- 2012-003230-17 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .