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A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
Phase 3 trial testing Rituximab SC in Non-Hodgkin's Lymphoma in 410 participants. Completed in 31 October 2017.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 410 |
| Start date | 15 February 2011 |
| Primary completion | 12 June 2012 |
| Estimated completion | 31 October 2017 |
| Sites | 152 locations across Italy, Colombia, Finland, Malaysia, Croatia, Denmark, New Zealand, Russia |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 83.1 | ± 36.7 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 134.6 | ± 43.2 |
Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymp
| Group | Value | 95% CI |
|---|---|---|
| Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 85.1 | 78.1 – 90.5 |
| Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 80.3 | 72.8 – 86.5 |
Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in the SPD; PR: ≥50% decrease in SPD o
| Group | Value | 95% CI |
|---|---|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 82.8 | 71.3 – 91.1 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 90.5 | 80.4 – 96.4 |
Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD; PR: ≥50% decrease in SPD o
| Group | Value | 95% CI |
|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 84.9 | 79.2 – 89.5 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 84.4 | 78.7 – 89.1 |
Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates
| Group | Value | 95% CI |
|---|---|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 25.0 | 15.0 – 37.4 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 42.9 | 30.5 – 56.0 |
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates
| Group | Value | 95% CI |
|---|---|---|
| Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 34.8 | 26.9 – 43.2 |
| Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 28.2 | 20.9 – 36.3 |
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates
| Group | Value | 95% CI |
|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 31.7 | 25.4 – 38.6 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 32.2 | 25.9 – 39.1 |
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates
| Group | Value | 95% CI |
|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 57.9 | 50.3 – 65.2 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 50.6 | 42.9 – 58.3 |
Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the respons
| Group | Value | 95% CI |
|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 78.1 | 71.3 – 83.9 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 77.9 | 71.0 – 83.9 |
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
| Group | Value | 95% CI |
|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 34.6 | |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 31.7 |
PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one nod
| Group | Value | 95% CI |
|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA | NA – NA |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA | NA – NA |
Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
| Group | Value | 95% CI |
|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 36.1 | |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 35.1 |
Time frame: Baseline up to data cutoff date of 31 Oct 2017 (up to 6 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Stage I and II: Rituximab … | Stage I and II: Rituximab … |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Pyrexia | General disorders | — | — |
| Neutropenic sepsis | Infections and infestations | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Cystitis | Infections and infestations | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Bronchitis | Infections and infestations | — | — |
| Infection | Infections and infestations | — | — |
| Meningitis | Infections and infestations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Hydronephrosis | Renal and urinary disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Death | General disorders | — | — |
| Reaction | System | Stage I and II: Rituximab … | Stage I and II: Rituximab … |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Injection site erythema | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Chills | General disorders | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Injection site pain | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Chest pain | General disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
Most-reported serious reactions: Febrile neutropenia, Pneumonia, Neutropenia, Pyrexia, Neutropenic sepsis, Pulmonary embolism, Sepsis, Constipation.
Data from ClinicalTrials.gov NCT01200758 adverse events section.
This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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