Back to resultsA 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
Primary Purpose
Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Bendamustine
Rituximab
Rituximab
Rituximab
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
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.
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.
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.
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.
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.
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.
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.
Percentage of Participants With Anti-Rituximab Antibodies Over Time
Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
Summary of Observed Serum Rituximab Concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01724021
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
743 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Intervention Description
Standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Intervention Description
Standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda
Intervention Description
Standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
375 mg/m2 IV, Day 1 Cycles 1-4
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
1400 mg SC, Day 1 Cycles 5-8
Primary Outcome Measure Information:
Title
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Description
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.
Time Frame
Cycle 6 (Up to 24 weeks)
Title
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Description
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.
Time Frame
Cycle 8 (Up to 32 weeks)
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (AEs)
Description
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.
Time Frame
Randomization of first participant to clinical cutoff date (Up to 4 years)
Title
Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Description
Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion
Time Frame
Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Title
Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
Description
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.
Time Frame
During Cycle 4, 8 of treatment (Up to 32 weeks)
Title
Rituximab Administration Satisfaction Questionnaire (RASQ) Score
Description
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.
Time Frame
During Cycle 4, 8 of treatment (Up to 32 weeks)
Title
Complete Response (CR) Rate
Description
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.
Time Frame
28 days (± 3 days) after Day 1 of the last dose of induction treatment
Title
Event-free Survival (EFS)
Description
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.
Time Frame
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Title
Disease-free Survival (DFS)
Description
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.
Time Frame
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death from any cause.
Time Frame
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Title
Percentage of Participants With Anti-Rituximab Antibodies Over Time
Time Frame
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Title
Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
Time Frame
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Title
Summary of Observed Serum Rituximab Concentration
Time Frame
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
City
Santa Fé
ZIP/Postal Code
3000
Country
Argentina
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
City
Krems
ZIP/Postal Code
3500
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Steyr
ZIP/Postal Code
4400
Country
Austria
City
Wien
ZIP/Postal Code
1140
Country
Austria
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-320
Country
Brazil
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36010-510
Country
Brazil
City
Varginha
State/Province
MG
ZIP/Postal Code
37062-770
Country
Brazil
City
Recife
State/Province
PE
ZIP/Postal Code
50070-550
Country
Brazil
City
Curitiba
State/Province
PR
ZIP/Postal Code
81520-060
Country
Brazil
City
Londrina
State/Province
PR
ZIP/Postal Code
86050-190
Country
Brazil
City
Caxias do Sul
State/Province
RS
ZIP/Postal Code
95070-560
Country
Brazil
City
Novo Hamburgo
State/Province
RS
ZIP/Postal Code
93510-250
Country
Brazil
City
Santa Maria
State/Province
RS
ZIP/Postal Code
97015-373
Country
Brazil
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Santiago
ZIP/Postal Code
8380000
Country
Chile
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
City
Viña del Mar
ZIP/Postal Code
2520612
Country
Chile
City
Monteria
Country
Colombia
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
City
Santiago de los Caballeros
ZIP/Postal Code
51000
Country
Dominican Republic
City
Alexandria
ZIP/Postal Code
11737
Country
Egypt
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
City
San Salvador
ZIP/Postal Code
1101
Country
El Salvador
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
City
Berlin
ZIP/Postal Code
10559
Country
Germany
City
Berlin
ZIP/Postal Code
10967
Country
Germany
City
Berlin
ZIP/Postal Code
12351
Country
Germany
City
Berlin
ZIP/Postal Code
13581
Country
Germany
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
City
Bochum
ZIP/Postal Code
44787
Country
Germany
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Bottrop
ZIP/Postal Code
46236
Country
Germany
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany
City
Bremen
ZIP/Postal Code
28177
Country
Germany
City
Bremerhaven
ZIP/Postal Code
27568
Country
Germany
City
Coesfeld
ZIP/Postal Code
48653
Country
Germany
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
City
Darmstadt
ZIP/Postal Code
64295
Country
Germany
City
Dresden
ZIP/Postal Code
01127
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
Eisenach
ZIP/Postal Code
99817
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Essen
ZIP/Postal Code
45239
Country
Germany
City
Frankfurt an der Oder
ZIP/Postal Code
15236
Country
Germany
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
City
Fürth
ZIP/Postal Code
90766
Country
Germany
City
Georgsmarienhütte
ZIP/Postal Code
49124
Country
Germany
City
Giessen
ZIP/Postal Code
35392
Country
Germany
City
Giessen
Country
Germany
City
Goslar
ZIP/Postal Code
38642
Country
Germany
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
City
Halle
ZIP/Postal Code
06110
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
City
Hamm
ZIP/Postal Code
59063
Country
Germany
City
Hamm
ZIP/Postal Code
59071
Country
Germany
City
Hanau
ZIP/Postal Code
63450
Country
Germany
City
Hannover
ZIP/Postal Code
30171
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Herford
ZIP/Postal Code
32049
Country
Germany
City
Jena
ZIP/Postal Code
07747
Country
Germany
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
City
Kassel
ZIP/Postal Code
34125
Country
Germany
City
Köln
ZIP/Postal Code
50677
Country
Germany
City
Leer
ZIP/Postal Code
26789
Country
Germany
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
City
Limburg
ZIP/Postal Code
65549
Country
Germany
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
City
Mainz
ZIP/Postal Code
55122
Country
Germany
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
City
Marburg
ZIP/Postal Code
35037
Country
Germany
City
Mayen
ZIP/Postal Code
56727
Country
Germany
City
Moers
ZIP/Postal Code
47441
Country
Germany
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
City
Mönchengladbach
ZIP/Postal Code
41239
Country
Germany
City
Mülheim
ZIP/Postal Code
45468
Country
Germany
City
München
ZIP/Postal Code
80804
Country
Germany
City
Münster
ZIP/Postal Code
48149
Country
Germany
City
Neunkirchen/Saar
ZIP/Postal Code
66538
Country
Germany
City
Nürnberg
ZIP/Postal Code
90449
Country
Germany
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
City
Osnabrueck
ZIP/Postal Code
49076
Country
Germany
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
City
Pforzheim
ZIP/Postal Code
75179
Country
Germany
City
Pinneberg
ZIP/Postal Code
25421
Country
Germany
City
Pirna
ZIP/Postal Code
01796
Country
Germany
City
Porta Westfalica
ZIP/Postal Code
32457
Country
Germany
City
Pößneck
ZIP/Postal Code
07381
Country
Germany
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Rostock
ZIP/Postal Code
18055
Country
Germany
City
Rostock
ZIP/Postal Code
18057
Country
Germany
City
Rostock
ZIP/Postal Code
18059
Country
Germany
City
Rostock
ZIP/Postal Code
18107
Country
Germany
City
Rötha
ZIP/Postal Code
04571
Country
Germany
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
City
Schwäbisch-Hall
ZIP/Postal Code
74523
Country
Germany
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
City
Stade
ZIP/Postal Code
21680
Country
Germany
City
Stendal
ZIP/Postal Code
39576
Country
Germany
City
Stuttgart
ZIP/Postal Code
70173
Country
Germany
City
Traunstein
ZIP/Postal Code
83278
Country
Germany
City
Trier
ZIP/Postal Code
54290
Country
Germany
City
Velbert
ZIP/Postal Code
42551
Country
Germany
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
City
Weilheim
ZIP/Postal Code
82362
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
City
Wilhelmshaven
ZIP/Postal Code
26382
Country
Germany
City
Witten
ZIP/Postal Code
58452
Country
Germany
City
Wuerselen
ZIP/Postal Code
52146
Country
Germany
City
Zittau
ZIP/Postal Code
02763
Country
Germany
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
City
Guatemala
ZIP/Postal Code
01-010
Country
Guatemala
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
City
Bandung
ZIP/Postal Code
40161
Country
Indonesia
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
City
Jogjakarta
ZIP/Postal Code
55284
Country
Indonesia
City
Surabaya
ZIP/Postal Code
60111
Country
Indonesia
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
City
Piacenza
State/Province
Emilia-Romagna
ZIP/Postal Code
29121
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
City
Cuneo
State/Province
Piemonte
ZIP/Postal Code
12100
Country
Italy
City
Brindisi
State/Province
Puglia
ZIP/Postal Code
72100
Country
Italy
City
Lecce
State/Province
Puglia
ZIP/Postal Code
73100
Country
Italy
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
City
Lido Di Camaiore
State/Province
Toscana
ZIP/Postal Code
55041
Country
Italy
City
Livorno
State/Province
Toscana
ZIP/Postal Code
57124
Country
Italy
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
City
Sabah
ZIP/Postal Code
88586
Country
Malaysia
City
Amstelveen
ZIP/Postal Code
1186 AH
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
City
Capelle Aan De Yssel
ZIP/Postal Code
2906 ZC
Country
Netherlands
City
Delftzijl
ZIP/Postal Code
9934 JD
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2566 MJ
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
City
Goes
ZIP/Postal Code
4462 RA
Country
Netherlands
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
City
Auckland
Country
New Zealand
City
Panama City
ZIP/Postal Code
0832-00752
Country
Panama
City
Panama
ZIP/Postal Code
080814
Country
Panama
City
Panama
ZIP/Postal Code
0834-02723
Country
Panama
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
City
Cusco
ZIP/Postal Code
08006
Country
Peru
City
La Victoria, Lima
ZIP/Postal Code
Lima 13
Country
Peru
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Manila
ZIP/Postal Code
1003
Country
Philippines
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
City
Ponta Delgada
ZIP/Postal Code
9500-370
Country
Portugal
City
Setubal
ZIP/Postal Code
2910-446
Country
Portugal
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
City
Brasov
ZIP/Postal Code
500152
Country
Romania
City
Brasov
ZIP/Postal Code
500326
Country
Romania
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
City
Craiova
ZIP/Postal Code
200143
Country
Romania
City
Iasi
ZIP/Postal Code
700483
Country
Romania
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
City
Falun
ZIP/Postal Code
79182
Country
Sweden
City
Göteborg
ZIP/Postal Code
S-413 45
Country
Sweden
City
Jönköping
ZIP/Postal Code
551_85
Country
Sweden
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
City
Sundsvall
ZIP/Postal Code
85186
Country
Sweden
City
Västerås
ZIP/Postal Code
SE-71 289
Country
Sweden
City
Kaohsung
ZIP/Postal Code
883
Country
Taiwan
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
City
Erzurum
ZIP/Postal Code
25050
Country
Turkey
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
City
Ha Noi
ZIP/Postal Code
70000
Country
Vietnam
City
Hochiminh city
ZIP/Postal Code
70000
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
28031173
Citation
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.
Results Reference
derived
PubMed Identifier
27695295
Citation
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.
Results Reference
derived
Learn more about this trial
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
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