Overview

This trial is active, not recruiting.

Condition lymphoma, large b-cell, diffuse
Treatments chop, rituximab [mabthera/rituxan]
Phase phase 3
Target CD20
Sponsor Hoffmann-La Roche
Start date August 2012
End date September 2016
Trial size 576 participants
Trial identifier NCT01649856, 2012-000669-19, MO28107

Summary

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

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
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
rituximab [mabthera/rituxan]
The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles
(Active Comparator)
chop
CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
rituximab [mabthera/rituxan]
375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Primary Outcomes

Measure
Complete response rate (CR/CRu) , assessed by Investigator according to International Working Group criteria (Cheeson et al., 1999), at the end of induction treatment
time frame: approximately 21 months

Secondary Outcomes

Measure
Patient satisfaction: Validated Cancer Treatment Satisfaction Questionnaire (CTSQ)/Rituximab Administration Satisfaction Questionnaire (RASQ)
time frame: approximately 21 months
Administration times (iv versus sc)
time frame: approximately 21 months
Event-free survival
time frame: approximately 4 years
Disease-free survival
time frame: approximately 4 years
Progression-free survival
time frame: approximately 4 years
Overall survival
time frame: approximately 4 years
Safety: Incidence of adverse events
time frame: approximately 4 years

Eligibility Criteria

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

Inclusion Criteria: - Adult patients, >/= 18 and /= 7.5 cm - At least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI - Adequate hematologic function - Eastern Cooperative Oncology Group (EOCD) performance status /= 5 years prior to enrolment - Inadequate renal or hepatic function - Known human immunodeficiency virus (HIV) infection or HIV seropositive status - Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative. - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products - Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines - Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody - Pregnant or lactating women

Additional Information

Official title A Comparative, Randomized, Parallel-group, Multi-centre, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20 Positive Diffuse Large B-cell Lymphoma (DLBCL)
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.