Phase 3
Completed N=139
Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
Source: ClinicalTrials.gov NCT02406092 ↗Enrolled (actual)
139
Serious AEs
15.6%
Results posted
Nov 2024
Primary outcomePrimary: Percentage of Participants With Administration-Associated Reactions (AARs) — 1.1; 3.7; 1.6; 1.1 Percentage of Participants %
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Administration-Associated Reactions (AARs) |
1.1; 3.7; 1.6; 1.1; 0; 0.8 | — |
| SECONDARY Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria |
NA; 53.8; 53.8; NA; 45.5; 45.5 | — |
| SECONDARY Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria |
NA; 53.8; 53.8; NA; 45.5; 44.5 | — |
| SECONDARY Overall Survival (OS) |
51.4; NA; NA; 51.4; NA; NA | — |
| SECONDARY Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria |
NA; NA; NA | — |
| SECONDARY Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria |
74.2; 76.5; 74.5 | — |
| SECONDARY Healthcare Professional Questionnaire Score |
— | — |
| SECONDARY Patient-Reported Rituximab Administration Questionnaire (RASQ) Score |
70.5; 69.2; 70.2 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, cluster of differentiation (CD)20+ DLBCL or CD20+ follicular NHL grade 1 to 3a, according to the world health organization (WHO) classification system
- Currently being treated with rituximab IV in the Induction or Maintenance setting, 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 because of tolerability issues
- Expectation and current ability for the participants to receive at least four additional cycles of treatment during the Induction phase or six additional cycles of treatment during the Maintenance phase (participants with follicular NHL)
Exclusion Criteria
- Transformed lymphoma or FL IIIB
- History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for greater than or equal to (>/=) 5 years prior to dosing
Data sourced from ClinicalTrials.gov (NCT02406092). 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.