Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments mabthera/rituxan, standard chemotherapy
Phase phase 3
Target CD20
Sponsor Hoffmann-La Roche
Start date July 2013
End date June 2019
Trial size 161 participants
Trial identifier NCT01889069, 2013-000647-12, ML28881

Summary

This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetics of subcutaneous (SC) MabThera/Rituxan (rituximab) in previously untreated patients with CD20+ diffuse large B cell lymphoma (DLBCL) or follicular lymphoma (FL). Patients will receive in addition to standard chemotherapy, in the induction phase of the study subcutaneous doses of 1400 mg MabThera/Rituxan once a month for at least 4 cycles, and in the maintenance phase subcutaneous doses of 1400 mg MabThera/Rituxan once every two months for at least 6 cycles.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mabthera/rituxan
Induction: Subcutaneous doses of 1400 mg once a months for at least 4 cycles; Maintenance: Subcutaneous doses of 1400 mg once every two months for at least 6 cycles
standard chemotherapy
Standard chemotherapy: CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), CVP (cyclophosphamide, vincristine and prednisone) or bendamustine, as per standard local practice.

Primary Outcomes

Measure
Safety: Incidence of Administration-associated reactions
time frame: Approximately 6 years

Secondary Outcomes

Measure
Safety: Incidence of adverse events
time frame: Approximately 6 years
Event-free survival (EFS)
time frame: Approximately 6 years
Progression-free survival (PFS)
time frame: Approximately 6 years
Overall survival (OS)
time frame: Approximately 6 years
Disease-free survival (DFS)
time frame: Approximately 6 years
Complete response rate (CRR)
time frame: Approximately 6 years
Follicular lymphoma patients: plasma concentration of rituximab
time frame: Induction: Pre-dose of rituximab administration and pre-dose at Cycle 8, Day 1; maintenance: Pre-dose of rituximab administration and pre-dose Cycle 12, Day 1
Diffuse large B-cell lymphoma patients: plasma concentration of rituximab
time frame: Induction: pre-dose of rituximab administration, pre-dose Cycle 7, Day 1; Cycle 7, Day 7; Cycle 7, Day 14; pre-dose Cycle 8, Day 1
Patient-assessed satisfaction using Rituximab Administration Satisfaction Questionnaire (RASQ)
time frame: Approximately 6 years

Eligibility Criteria

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

Inclusion Criteria: - Adult patients, age >/= 18 and /= 7.5 cm, or Follicular Lymphoma International Prognostic Index (FLIPI) - At least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on computed tomography (CT) scan - Eastern Cooperative Oncology Group (ECOG) performance status 30 mg/day of prednisone or equivalent - Inadequate renal and hematologic or hepatic function - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products - Contraindications to any of the individual components of standard chemotherapy - Other serious underlying medical conditions, which, in the Investigator's judgement, could impair the ability of the patient to participate in the study - Recent major surgery (within 4 weeks prior to dosing, other than for diagnosis) - Active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection

Additional Information

Official title A Single Arm, Multicenter, Phase IIIb Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.