Phase 3
Completed N=740
A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a
Source: ClinicalTrials.gov NCT01724021 ↗Enrolled (actual)
740
Serious AEs
32.7%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 — 79.1; 80.6 percentage of participants
◆ Published Evidence
Highly cited
150citations · ~17 / year
Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab).
Summary
This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants 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. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants 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.
Linked Publications (2)
-
Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab).
-
Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 |
79.1; 80.6 | — |
| PRIMARY Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8 |
77.1; 84.2 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) |
352; 347 | — |
| SECONDARY Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV]) |
840; 22 | — |
| SECONDARY Cancer Therapy Satisfaction Questionnaire (CTSQ) Score |
80.88; 82.07; 60.63; 61.64; 84.59; 85.42 | — |
| SECONDARY Rituximab Administration Satisfaction Questionnaire (RASQ) Score |
82.14; 82.08; 77.73; 84.00; 59.49; 81.86 | — |
| SECONDARY Complete Response (CR) Rate |
49.2; 52.7 | — |
| SECONDARY Event-free Survival (EFS) |
NA; NA | — |
| SECONDARY Disease-free Survival (DFS) |
NA; NA | — |
| SECONDARY Progression-free Survival (PFS) |
NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Percentage of Participants With Anti-Rituximab Antibodies Over Time |
2.0; 3.0; 2.1; 2.2; 0.3; 0.9 | — |
| SECONDARY Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time |
11.4; 15.6; 7.0; 18.2; 7.1; 23.5 | — |
| SECONDARY Summary of Observed Serum Rituximab Concentration |
3355.9; 970.1; 25053.1; 24541.1; 62977.0; 46093.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants , >/= 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; participants 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
Data sourced from ClinicalTrials.gov (NCT01724021) and the linked publication. 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. Informational only — not medical advice.