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 - Full Text View

Purpose

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
Lymphoma, B-Cell, Non-Hodgkin's Lymphoma	Drug: rituximab [MabThera/Rituxan] Drug: CHOP Drug: CVP Drug: bendamustine	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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Bendamustine hydrochloride Bendamustine Rituximab

U.S. FDA Resources

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:	February 2016
Estimated Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A: SC - IV	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 Drug: CHOP standard chemotherapy Drug: CVP standard chemotherapy Drug: bendamustine standard chemotherapy
Experimental: B: IV -SC	Drug: rituximab [MabThera/Rituxan] 1400 mg SC, Day 1 Cycles 5-8 Drug: rituximab [MabThera/Rituxan] 375 mg/m2 IV, Day 1 Cycles 1-4 Drug: CHOP standard chemotherapy Drug: CVP standard chemotherapy Drug: bendamustine standard chemotherapy

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

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

Contacts

Contact: Please reference Study ID Number: MO28457 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 202 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:	May 13, 2013
Health Authority:	Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Bendamustine
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013