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

NCT ID: NCT01724021

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 743 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-01-31

Brief 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. 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.

Conditions

Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Standard chemotherapy

Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Intervention Type: DRUG

Standard chemotherapy

Bendamustine

Intervention Type: DRUG

Standard chemotherapy

Rituximab

Intervention Type: DRUG

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

Rituximab

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Standard chemotherapy

Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Intervention Type: DRUG

Standard chemotherapy

Bendamustine

Intervention Type: DRUG

Standard chemotherapy

Rituximab

Intervention Type: DRUG

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

Rituximab

Intervention Type: DRUG

1400 mg SC, Day 1 Cycles 5-8

Interventions

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

Standard chemotherapy

Intervention Type: DRUG

Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Standard chemotherapy

Intervention Type: DRUG

Bendamustine

Standard chemotherapy

Intervention Type: DRUG

Rituximab

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

Intervention Type: DRUG

Rituximab

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

Intervention Type: DRUG

Rituximab

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

Intervention Type: DRUG

Rituximab

1400 mg SC, Day 1 Cycles 5-8

Intervention Type: DRUG

Other Intervention Names

Treanda; Rituxan; MabThera; Rituxan; MabThera; Rituxan; MabThera; Rituxan; MabThera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Buenos Aires, , Argentina

Corrientes, , Argentina

Santa Fé, , Argentina

Canberra, Australian Capital Territory, Australia

Camperdown, New South Wales, Australia

Liverpool, New South Wales, Australia

Randwick, New South Wales, Australia

Brisbane, Queensland, Australia

Adelaide, South Australia, Australia

Hobart, Tasmania, Australia

Geelong, Victoria, Australia

Malvern, Victoria, Australia

Melbourne, Victoria, Australia

Wodonga, Victoria, Australia

Nedlands, Western Australia, Australia

Perth, Western Australia, Australia

Krems, , Austria

Linz, , Austria

Salzburg, , Austria

Steyr, , Austria

Vienna, , Austria

Belo Horizonte, Minas Gerais, Brazil

Juiz de Fora, Minas Gerais, Brazil

Varginha, Minas Gerais, Brazil

Curitiba, Paraná, Brazil

Londrina, Paraná, Brazil

Recife, Pernambuco, Brazil

Caxias do Sul, Rio Grande do Sul, Brazil

Novo Hamburgo, Rio Grande do Sul, Brazil

Santa Maria, Rio Grande do Sul, Brazil

Santo André, São Paulo, Brazil

São José do Rio Preto, São Paulo, Brazil

Burnaby, British Columbia, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Hamilton, Ontario, Canada

Montreal, Quebec, Canada

Santiago, , Chile

Santiago, , Chile

Viña del Mar, , Chile

Montería, , Colombia

Osijek, , Croatia

Aalborg, , Denmark

Holstebro, , Denmark

Santiago de los Caballeros, , Dominican Republic

Alexandria, , Egypt

Cairo, , Egypt

San Salvador, , El Salvador

Aschaffenburg, , Germany

Augsburg, , Germany

Bamberg, , Germany

Bayreuth, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bielefeld, , Germany

Bielefeld, , Germany

Bochum, , Germany

Bochum, , Germany

Bonn, , Germany

Bottrop, , Germany

Brandenburg, , Germany

Bremen, , Germany

Bremerhaven, , Germany

Coesfeld, , Germany

Cologne, , Germany

Darmstadt, , Germany

Darmstadt, , Germany

Dresden, , Germany

Dresden, , Germany

Düsseldorf, , Germany

Eisenach, , Germany

Essen, , Germany

Essen, , Germany

Frankfurt, , Germany

Frankfurt, , Germany

Frankfurt, , Germany

Frankfurt (Oder), , Germany

Freiburg im Breisgau, , Germany

Fürth, , Germany

Georgsmarienhütte, , Germany

Giessen, , Germany

Giessen, , Germany

Goslar, , Germany

Gütersloh, , Germany

Halle, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamm, , Germany

Hamm, , Germany

Hanau, , Germany

Hanover, , Germany

Hanover, , Germany

Herford, , Germany

Jena, , Germany

Kaiserslautern, , Germany

Kassel, , Germany

Leer, , Germany

Leipzig, , Germany

Limburg, , Germany

Lübeck, , Germany

Magdeburg, , Germany

Mainz, , Germany

Mannheim, , Germany

Marburg, , Germany

Mayen, , Germany

Moers, , Germany

Mönchengladbach, , Germany

Mutlangen, , Germany

Mülheim, , Germany

München, , Germany

Münster, , Germany

Neunkirchen/Saar, , Germany

Nuremberg, , Germany

Oldenburg, , Germany

Osnabrück, , Germany

Paderborn, , Germany

Pforzheim, , Germany

Pinneberg, , Germany

Pirna, , Germany

Porta Westfalica, , Germany

Pößneck, , Germany

Ravensburg, , Germany

Recklinghausen, , Germany

Regensburg, , Germany

Rostock, , Germany

Rostock, , Germany

Rostock, , Germany

Rostock, , Germany

Rötha, , Germany

Schwäbisch Hall, , Germany

Schweinfurt, , Germany

Siegburg, , Germany

Stade, , Germany

Stendal, , Germany

Stuttgart, , Germany

Traunstein, , Germany

Trier, , Germany

Velbert, , Germany

Villingen-Schwenningen, , Germany

Weilheim, , Germany

Wiesbaden, , Germany

Wilhelmshaven, , Germany

Witten, , Germany

Würselen, , Germany

Zittau, , Germany

Zwickau, , Germany

Guatemala City, , Guatemala

Guatemala City, , Guatemala

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Budapest, , Hungary

Győr, , Hungary

Gyula, , Hungary

Kaposvár, , Hungary

Nyíregyháza, , Hungary

Szeged, , Hungary

Szolnok, , Hungary

Bandung, , Indonesia

Jakarta, , Indonesia

Surabaya, , Indonesia

Yogyakarta, , Indonesia

Brindisi, Apulia, Italy

Lecce, Apulia, Italy

Catanzaro, Calabria, Italy

Ferrara, Emilia-Romagna, Italy

Parma, Emilia-Romagna, Italy

Piacenza, Emilia-Romagna, Italy

Rome, Lazio, Italy

Candiolo, Piedmont, Italy

Cuneo, Piedmont, Italy

Palermo, Sicily, Italy

Lido di Camaiore, Tuscany, Italy

Livorno, Tuscany, Italy

Ampang, , Malaysia

Kuala Lumpur, , Malaysia

Kuching, , Malaysia

Sabak Bernam, , Malaysia

Amstelveen, , Netherlands

Amsterdam, , Netherlands

Apeldoorn, , Netherlands

Beverwijk, , Netherlands

Capelle aan den IJssel, , Netherlands

Delftzijl, , Netherlands

Eindhoven, , Netherlands

Goes, , Netherlands

Leidschendam, , Netherlands

Rotterdam, , Netherlands

The Hague, , Netherlands

The Hague, , Netherlands

Tilburg, , Netherlands

Utrecht, , Netherlands

Auckland, , New Zealand

Panama City, , Panama

Panama City, , Panama

Panama City, , Panama

Arequipa, , Peru

Cusco, , Peru

La Victoria, Lima, , Peru

Cebu City, , Philippines

Manila, , Philippines

Manila, , Philippines

Quezon City, , Philippines

Lisbon, , Portugal

Matosinhos Municipality, , Portugal

Ponta Delgada, , Portugal

Setúbal, , Portugal

Viseu, , Portugal

Baia Mare, , Romania

Brasov, , Romania

Brasov, , Romania

Bucharest, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Craiova, , Romania

Iași, , Romania

Sibiu, , Romania

Timișoara, , Romania

Busan, , South Korea

Daegu, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Falun, , Sweden

Gothenburg, , Sweden

Jönköping, , Sweden

Karlstad, , Sweden

Sundsvall, , Sweden

Västerås, , Sweden

Kaohsung, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Bangkok, , Thailand

Bangkok, , Thailand

Bangkok, , Thailand

Chiang Mai, , Thailand

Khon Kaen, , Thailand

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Denizli, , Turkey (Türkiye)

Erzurum, , Turkey (Türkiye)

Malatya, , Turkey (Türkiye)

Hà Nội, , Vietnam

Hochiminh City, , Vietnam

Countries

Argentina; Australia; Austria; Brazil; Canada; Chile; Colombia; Croatia; Denmark; Dominican Republic; Egypt; El Salvador; Germany; Guatemala; Hong Kong; Hungary; Indonesia; Italy; Malaysia; Netherlands; New Zealand; Panama; Peru; Philippines; Portugal; Romania; South Korea; Sweden; Taiwan; Thailand; Turkey (Türkiye); Vietnam

References

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.

Reference Type: DERIVED

PMID: 28031173 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27695295 (View on PubMed)

Other Identifiers

2012-003230-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO28457

Identifier Type: -

Identifier Source: org_study_id