Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01724021
First received: November 5, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This multi-center, open-label, randomized study will evaluate the patient prefer ence with subcutaneous versus intravenous administration of MabThera/Rituxan (ri tuximab) in patients with CD20+ diffuse large B-cell lymphoma or CD20+ follicula r non-Hodgkin's lymphoma. In Arm A, patients will receive MabThera/Rituxan 375 m g/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcuta neously (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 C ycles 5-8. All patients will receive 6-8 cycles of standard chemotherapy (accord ing to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated ti me on study treatment is up to 24 weeks.


Condition Intervention Phase
Lymphoma, B-Cell, 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) 4-8 weeks 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 ]

Estimated Enrollment: 900
Study Start Date: December 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, blastic variant of mantle-cell 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 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

Contacts
Contact: Reference Study ID Number: MO28457 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 245 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: November 24, 2014
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014