AzTrials
AzTrials

Diffuse Large B-Cell Lymphoma, Non-Hodgkin's LymphomaPhase 3NCT01724021

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

A Phase 3 study testing Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP), Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP) and Bendamustine in people with Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 246 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP), Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP) and Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
743 participants
Where
246 sitesin 32 countries
Study dates
Dec 2012to Jan 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

246 sites in 32 countries.

246 sites in 32 countries

Germany101 sites

  • Study site

    Aschaffenburg, 63739

  • Study site

    Augsburg, 86150

  • Study site

    Bamberg, 96049

  • Study site

    Bayreuth, 95445

  • Study site

    Berlin, 10559

  • Study site

    Berlin, 10967

  • Study site

    Berlin, 12351

  • Study site

    Berlin, 13581

  • Study site

    Bielefeld, 33604

  • Study site

    Bielefeld, 33611

  • Study site

    Bochum, 44787

  • Study site

    Bochum, 44791

  • Study site

    Bonn, 53127

  • Study site

    Bottrop, 46236

  • Study site

    Brandenburg, 14770

  • Study site

    Bremen, 28177

  • Study site

    Bremerhaven, 27568

  • Study site

    Coesfeld, 48653

  • Study site

    Cologne, 50677

  • Study site

    Darmstadt, 64283

  • Study site

    Darmstadt, 64295

  • Study site

    Dresden, 01127

  • Study site

    Dresden, 01307

  • Study site

    Düsseldorf, 40225

  • Study site

    Eisenach, 99817

  • Study site

    Essen, 45122

  • Study site

    Essen, 45239

  • Study site

    Frankfurt, 60389

  • Study site

    Frankfurt, 60488

  • Study site

    Frankfurt, 60596

  • Study site

    Frankfurt (Oder), 15236

  • Study site

    Freiburg im Breisgau, 79110

  • Study site

    Fürth, 90766

  • Study site

    Georgsmarienhütte, 49124

  • Study site

    Giessen, 35392

  • Study site

    Giessen

  • Study site

    Goslar, 38642

  • Study site

    Gütersloh, 33332

  • Study site

    Halle, 06110

  • Study site

    Hamburg, 20246

  • Study site

    Hamburg, 22081

  • Study site

    Hamburg, 22457

  • Study site

    Hamm, 59063

  • Study site

    Hamm, 59071

  • Study site

    Hanau, 63450

  • Study site

    Hanover, 30171

  • Study site

    Hanover, 30625

  • Study site

    Herford, 32049

  • Study site

    Jena, 07747

  • Study site

    Kaiserslautern, 67655

  • Study site

    Kassel, 34125

  • Study site

    Leer, 26789

  • Study site

    Leipzig, 04289

  • Study site

    Limburg, 65549

  • Study site

    Lübeck, 23562

  • Study site

    Magdeburg, 39104

  • Study site

    Mainz, 55122

  • Study site

    Mannheim, 68161

  • Study site

    Marburg, 35037

  • Study site

    Mayen, 56727

  • Study site

    Moers, 47441

  • Study site

    Mönchengladbach, 41239

  • Study site

    Mülheim, 45468

  • Study site

    München, 80804

  • Study site

    Münster, 48149

  • Study site

    Mutlangen, 73557

  • Study site

    Neunkirchen/Saar, 66538

  • Study site

    Nuremberg, 90449

  • Study site

    Oldenburg, 26121

  • Study site

    Osnabrück, 49076

  • Study site

    Paderborn, 33098

  • Study site

    Pforzheim, 75179

  • Study site

    Pinneberg, 25421

  • Study site

    Pirna, 01796

  • Study site

    Porta Westfalica, 32457

  • Study site

    Pößneck, 07381

  • Study site

    Ravensburg, 88212

  • Study site

    Recklinghausen, 45657

  • Study site

    Regensburg, 93053

  • Study site

    Rostock, 18055

  • Study site

    Rostock, 18057

  • Study site

    Rostock, 18059

  • Study site

    Rostock, 18107

  • Study site

    Rötha, 04571

  • Study site

    Schwäbisch Hall, 74523

  • Study site

    Schweinfurt, 97422

  • Study site

    Siegburg, 53721

  • Study site

    Stade, 21680

  • Study site

    Stendal, 39576

  • Study site

    Stuttgart, 70173

  • Study site

    Traunstein, 83278

  • Study site

    Trier, 54290

  • Study site

    Velbert, 42551

  • Study site

    Villingen-Schwenningen, 78052

  • Study site

    Weilheim, 82362

  • Study site

    Wiesbaden, 65191

  • Study site

    Wilhelmshaven, 26382

  • Study site

    Witten, 58452

  • Study site

    Würselen, 52146

  • Study site

    Zittau, 02763

  • Study site

    Zwickau, 08060

Other trials in Germany

Netherlands14 sites

  • Study site

    Amstelveen, 1186 AH

  • Study site

    Amsterdam, 1091 AC

  • Study site

    Apeldoorn, 7334 DZ

  • Study site

    Beverwijk, 1942 LE

  • Study site

    Capelle aan den IJssel, 2906 ZC

  • Study site

    Delftzijl, 9934 JD

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Goes, 4462 RA

  • Study site

    Leidschendam, 2262 BA

  • Study site

    Rotterdam, 3045 PM

  • Study site

    The Hague, 2512 VA

  • Study site

    The Hague, 2566 MJ

  • Study site

    Tilburg, 5022 GC

  • Study site

    Utrecht, 3582 KE

Other trials in Netherlands

Australia13 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Brisbane, Queensland, 4101

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Canberra, Australian Capital Territory, 2605

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Liverpool, New South Wales, 2170

  • Study site

    Malvern, Victoria, 3144

  • Study site

    Melbourne, Victoria, 3084

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Randwick, New South Wales, 2031

  • Study site

    Wodonga, Victoria, 3690

Other trials in Australia

Italy12 sites

  • Study site

    Brindisi, Apulia, 72100

  • Study site

    Candiolo, Piedmont, 10060

  • Study site

    Catanzaro, Calabria, 88100

  • Study site

    Cuneo, Piedmont, 12100

  • Study site

    Ferrara, Emilia-Romagna, 44100

  • Study site

    Lecce, Apulia, 73100

  • Study site

    Lido di Camaiore, Tuscany, 55041

  • Study site

    Livorno, Tuscany, 57124

  • Study site

    Palermo, Sicily, 90146

  • Study site

    Parma, Emilia-Romagna, 43126

  • Study site

    Piacenza, Emilia-Romagna, 29121

  • Study site

    Rome, Lazio, 00133

Other trials in Italy

Brazil11 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-320

  • Study site

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Study site

    Curitiba, Paraná, 81520-060

  • Study site

    Juiz de Fora, Minas Gerais, 36010-510

  • Study site

    Londrina, Paraná, 86050-190

  • Study site

    Novo Hamburgo, Rio Grande do Sul, 93510-250

  • Study site

    Recife, Pernambuco, 50070-550

  • Study site

    Santa Maria, Rio Grande do Sul, 97015-373

  • Study site

    Santo André, São Paulo, 09060-650

  • Study site

    São José do Rio Preto, São Paulo, 15090-000

  • Study site

    Varginha, Minas Gerais, 37062-770

Other trials in Brazil

Romania11 sites

  • Study site

    Baia Mare, 430031

  • Study site

    Brasov, 500152

  • Study site

    Brasov, 500326

  • Study site

    Bucharest, 022328

  • Study site

    Bucharest, 030171

  • Study site

    Bucharest, 050098

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Craiova, 200143

  • Study site

    Iași, 700483

  • Study site

    Sibiu, 550245

  • Study site

    Timișoara, 300239

Other trials in Romania

Hungary7 sites

  • Study site

    Budapest, 1097

  • Study site

    Győr, 9024

  • Study site

    Gyula, 5700

  • Study site

    Kaposvár, 7400

  • Study site

    Nyíregyháza, 4400

  • Study site

    Szeged, 6720

  • Study site

    Szolnok, 5004

Other trials in Hungary

Sweden6 sites

  • Study site

    Falun, 79182

  • Study site

    Gothenburg, S-413 45

  • Study site

    Jönköping, 551_85

  • Study site

    Karlstad, 65185

  • Study site

    Sundsvall, 85186

  • Study site

    Västerås, SE-71 289

Other trials in Sweden

Austria5 sites

  • Study site

    Krems, 3500

  • Study site

    Linz, 4020

  • Study site

    Salzburg, 5020

  • Study site

    Steyr, 4400

  • Study site

    Vienna, 1140

Other trials in Austria

Canada5 sites

  • Study site

    Burnaby, British Columbia, V5G 2X6

  • Study site

    Hamilton, Ontario, L8V 5C2

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Portugal5 sites

  • Study site

    Lisbon, 1449-005

  • Study site

    Matosinhos Municipality, 4454-509

  • Study site

    Ponta Delgada, 9500-370

  • Study site

    Setúbal, 2910-446

  • Study site

    Viseu, 3504-509

Other trials in Portugal

Thailand5 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50200

  • Study site

    Khon Kaen, 40002

Other trials in Thailand

Turkey (Türkiye)5 sites

  • Study site

    Ankara, 06100

  • Study site

    Ankara, 06200

  • Study site

    Denizli, 20070

  • Study site

    Erzurum, 25050

  • Study site

    Malatya, 44280

Other trials in Turkey (Türkiye)

Indonesia4 sites

  • Study site

    Bandung, 40161

  • Study site

    Jakarta, 11420

  • Study site

    Surabaya, 60111

  • Study site

    Yogyakarta, 55284

Other trials in Indonesia

Malaysia4 sites

  • Study site

    Ampang, 68000

  • Study site

    Kuala Lumpur, 56000

  • Study site

    Kuching, 93586

  • Study site

    Sabak Bernam, 88586

Other trials in Malaysia

Philippines4 sites

  • Study site

    Cebu City, 6000

  • Study site

    Manila, 1000

  • Study site

    Manila, 1003

  • Study site

    Quezon City, 1100

Other trials in Philippines

South Korea4 sites

  • Study site

    Busan, 602-739

  • Study site

    Daegu, 41944

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 06591

Other trials in South Korea

Argentina3 sites

  • Study site

    Buenos Aires, 1425

  • Study site

    Corrientes, 3400

  • Study site

    Santa Fe, 3000

Other trials in Argentina

Chile3 sites

  • Study site

    Santiago, 8380000

  • Study site

    Santiago, 8420383

  • Study site

    Viña del Mar, 2520612

Other trials in Chile

Panama3 sites

  • Study site

    Panama City, 080814

  • Study site

    Panama City, 0832-00752

  • Study site

    Panama City, 0834-02723

Other trials in Panama

Peru3 sites

  • Study site

    Arequipa, 04001

  • Study site

    Cusco, 08006

  • Study site

    La Victoria, Lima, Lima 13

Other trials in Peru

Taiwan3 sites

  • Study site

    Kaohsung, 883

  • Study site

    Taichung, 40705

  • Study site

    Taipei, 100

Other trials in Taiwan

Denmark2 sites

  • Study site

    Aalborg, 9000

  • Study site

    Holstebro, 7500

Other trials in Denmark

Egypt2 sites

  • Study site

    Alexandria, 11737

  • Study site

    Cairo, 11562

Other trials in Egypt

Guatemala2 sites

  • Study site

    Guatemala City, 01-010

  • Study site

    Guatemala City, 01010

Other trials in Guatemala

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

Other trials in Hong Kong

Vietnam2 sites

  • Study site

    Hà Nội, 70000

  • Study site

    Hochiminh City, 70000

Other trials in Vietnam

Colombia1 site

  • Study site

    Montería

Other trials in Colombia

Croatia1 site

  • Study site

    Osijek, 31000

Other trials in Croatia

Dominican Republic1 site

  • Study site

    Santiago de los Caballeros, 51000

Other trials in Dominican Republic

El Salvador1 site

  • Study site

    San Salvador, 1101

Other trials in El Salvador

New Zealand1 site

  • Study site

    Auckland

Other trials in New Zealand

About this study

Official title: 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.

Being tested
Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP), Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP), Bendamustine, Rituximab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)Drug

    Standard chemotherapy

  • Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)Drug

    Standard chemotherapy

  • BendamustineDrug

    Also called Treanda

    Standard chemotherapy

  • RituximabDrug

    Also called Rituxan, MabThera

    1400 mg subcutaneously (SC), Day 1 Cycles 2-4

  • RituximabDrug

    Also called Rituxan, MabThera

    375 mg/m2 IV, Day 1 Cycles 1-4

  • RituximabDrug

    Also called Rituxan, MabThera

    375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8

  • RituximabDrug

    Also called Rituxan, MabThera

    1400 mg SC, Day 1 Cycles 5-8

Study groups in NCT01724021
Study groupRoleWhat they receive
Arm AExperimentalParticipants 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.
Receives: Drug: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP); Drug: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP); Drug: Bendamustine; Drug: Rituximab
Arm BExperimentalParticipants 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.
Receives: Drug: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP); Drug: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP); Drug: Bendamustine; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6

    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.

    Measured: Cycle 6 (Up to 24 weeks)

  2. Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8

    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.

    Measured: Cycle 8 (Up to 32 weeks)

Secondary outcomes (12)

  1. Number of Participants With Treatment Emergent Adverse Events (AEs)

    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.

    Measured: Randomization of first participant to clinical cutoff date (Up to 4 years)

  2. Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])

    Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion

    Measured: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)

  3. Cancer Therapy Satisfaction Questionnaire (CTSQ) Score

    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.

    Measured: During Cycle 4, 8 of treatment (Up to 32 weeks)

  4. Rituximab Administration Satisfaction Questionnaire (RASQ) Score

    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.

    Measured: During Cycle 4, 8 of treatment (Up to 32 weeks)

  5. Complete Response (CR) Rate

    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.

    Measured: 28 days (± 3 days) after Day 1 of the last dose of induction treatment

  6. Event-free Survival (EFS)

    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.

    Measured: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

  7. Disease-free Survival (DFS)

    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.

    Measured: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

  8. Progression-free Survival (PFS)

    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.

    Measured: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

  9. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause.

    Measured: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

  10. Percentage of Participants With Anti-Rituximab Antibodies Over Time

    Measured: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

  11. Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time

    Measured: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

  12. Summary of Observed Serum Rituximab Concentration

    Measured: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01724021
Sponsor's protocol ID
MO28457
Other IDs
2012-003230-17
Status last verified
Dec 2017
First submitted
5 Nov 2012
Last updated
23 Jan 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 28031173

  • 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.

    PubMed 27695295

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP), Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP) and Bendamustine in people with Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 246 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 246 sites in Germany, Netherlands, Australia, Italy, Brazil and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 (time frame: Cycle 6 (Up to 24 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01724021, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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