Phase 3 N=158 Treatment

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT01889069 ↗

Enrolled (actual)

158

Serious AEs

31.0%

Results posted

Aug 2020

Primary outcome: Primary: Percentage of Participants With Administration-Associated Reactions (AAR) — 4.2; 8.1; 6.3; 0 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rituximab (Drug); Cyclophosphamide (Drug); Vincristine (Drug); Doxorubicin (Drug); Prednisone (Drug); Bendamustine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Administration-Associated Reactions (AAR)	4.2; 8.1; 6.3; 0; 0; 0	—
SECONDARY Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs)	51.4; 43.0; 46.8	—
SECONDARY Percentage of Participants With At Least One Grade ≥ 3 Infusion/ Injection Related Reactions (IIRRs)	0; 0; 0	—
SECONDARY Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events	36.1; 26.7; 31.0	—
SECONDARY Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria	29.2; 22.1; 25.3	—
SECONDARY Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria	29.2; 22.1; 25.3	—
SECONDARY Percentage of Participants With Overall Survival (OS)	19.4; 4.7; 11.4	—
SECONDARY Percentage of Participants With Disease-Free Survival (DFS) According to IWG Response Criteria	21.7; 25.6; 23.5	—
SECONDARY Percentage of Participants With Complete Response (CR) According to IWG Response Criteria	65.2; 67.9; 66.4	—
SECONDARY FL: Plasma Trough Concentrations of Rituximab	55.49; 119.50; 157.25; 7.60; 90.88; 201.56	—
SECONDARY FL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab	61.01	—
SECONDARY FL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)	48.86; 156.33; 200.33; 7.60; 97.90; 284.08	—
SECONDARY DLBCL: Plasma Concentrations of Rituximab	42.53; 88.92; 110.50; 100.20; 92.92; 141.44	—
SECONDARY DLBCL: Plasma Trough Concentrations of Rituximab	42.53; 88.92; 110.50; 100.20; 92.92; 141.44	—
SECONDARY DLBCL: Area Under the Plasma Concentration-Time Curve (AUC) of Rituximab	NA	—
SECONDARY DLBCL: Maximum Plasma Concentration (Cmax) of Rituximab	NA	—
SECONDARY DLBCL: Apparent Total Clearance (CL/F) of Rituximab	NA	—
SECONDARY DLBCL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)	53.97; 101.79; 110.50; 121.67; 109.40; 157.93	—
SECONDARY DLBCL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab	70.50	—
SECONDARY DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21	170.00; 28.37; 88.92; 110.50; 125.00; 94.00	—
SECONDARY Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores	81.8; 76.5; 79.6; 95.8; 83.1; 75.0	—

Summary

This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period.

Eligibility Criteria

Inclusion Criteria

Histologically confirmed, CD20+ DLBCL or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, according to the World Health Organization (WHO) classification system
Currently being treated with rituximab intravenously (IV) in the Induction or Maintenance period, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square-meter (mg/m^2) administered without interruption or early discontinuation (i.e. tolerability issues)
Expectation and current ability for the participant to receive at least 4 additional cycles of treatment during the Induction period or 6 additional cycles of treatment during the Maintenance period (participants with follicular NHL)
An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion greater than or equal to (>=) 7.5 centimeters (cm), or Follicular Lymphoma International Prognostic Index (FLIPI) (low, intermediate or high risk) assessed before the first rituximab IV administration in Induction period
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 less than or equal to ( ) 30 milligrams per day (mg/day) of prednisone or equivalent
Inadequate renal, 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 participant 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

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Data sourced from ClinicalTrials.gov (NCT01889069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.