A Study of Patient Preference With Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Patients With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 5, 2012
Last updated: March 1, 2016
Last verified: March 2016
This multi-center, open-label, randomized study will evaluate the patient preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in patients with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, patients 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. Patients in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All patients 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.

Condition Intervention Phase
Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
Drug: CHOP
Drug: CVP
Drug: bendamustine
Drug: rituximab [MabThera/Rituxan]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients indicating an overall preference via Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or intravenous (IV) administration of MabThera/Rituxan [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Administration time SC vs IV [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Patient assessed satisfaction SC vs IV: Cancer Therapy Satisfaction Questionnaire (CTSQ)/Rituximab Administration Satisfaction Questionnaire (RASQ) [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Complete response (CR) rate including complete response unconfirmed (CRu), 28 days (+/- 3) after last dose of induction treatment [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Event-free survival (EFS) [ Time Frame: up to approximately 3.5 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS) [ Time Frame: up to approximately 3.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: up to approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: up to approximately 3.5 years ] [ Designated as safety issue: No ]
  • Immunogenicity: Anti-rituximab and anti-human recombinant hyaluronidase [rHuPH20] antibodies, associated rituximab concentration level [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Enrollment: 746
Study Start Date: December 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: SC - IV Drug: CHOP
standard chemotherapy
Drug: CVP
standard chemotherapy
Drug: bendamustine
standard chemotherapy
Drug: rituximab [MabThera/Rituxan]
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
Experimental: B: IV -SC Drug: CHOP
standard chemotherapy
Drug: CVP
standard chemotherapy
Drug: bendamustine
standard chemotherapy
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 IV, Day 1 Cycles 1-4
Drug: rituximab [MabThera/Rituxan]
1400 mg SC, Day 1 Cycles 5-8


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 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 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; patients 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724021

  Show 246 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01724021     History of Changes
Other Study ID Numbers: MO28457  2012-003230-17 
Study First Received: November 5, 2012
Last Updated: March 1, 2016
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2016