Overview

This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma, non-hodgkin's lymphoma
Treatments chop, cvp, bendamustine, rituximab [mabthera/rituxan]
Phase phase 3
Target CD20
Sponsor Hoffmann-La Roche
Start date December 2012
End date March 2017
Trial size 746 participants
Trial identifier NCT01724021, 2012-003230-17, MO28457

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
chop
standard chemotherapy
cvp
standard chemotherapy
bendamustine
standard chemotherapy
rituximab [mabthera/rituxan]
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
rituximab [mabthera/rituxan]
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
(Experimental)
chop
standard chemotherapy
cvp
standard chemotherapy
bendamustine
standard chemotherapy
rituximab [mabthera/rituxan]
375 mg/m2 IV, Day 1 Cycles 1-4
rituximab [mabthera/rituxan]
1400 mg SC, Day 1 Cycles 5-8

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Safety: Incidence of adverse events
time frame: approximately 3.5 years
Administration time SC vs IV
time frame: approximately 1.5 years
Patient assessed satisfaction SC vs IV: Cancer Therapy Satisfaction Questionnaire (CTSQ)/Rituximab Administration Satisfaction Questionnaire (RASQ)
time frame: approximately 1.5 years
Complete response (CR) rate including complete response unconfirmed (CRu), 28 days (+/- 3) after last dose of induction treatment
time frame: approximately 1.5 years
Event-free survival (EFS)
time frame: up to approximately 3.5 years
Disease-free survival (DFS)
time frame: up to approximately 3.5 years
Progression-free survival (PFS)
time frame: up to approximately 3.5 years
Overall survival (OS)
time frame: up to approximately 3.5 years
Immunogenicity: Anti-rituximab and anti-human recombinant hyaluronidase [rHuPH20] antibodies, associated rituximab concentration level
time frame: approximately 3.5 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Adult patients, >/= 18 and /= 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 /= 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.