Non-Hodgkin's Lymphoma
Conditions
Brief summary
This prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma. Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.
Interventions
DRUGRituximab
Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological diagnosis of follicular non-Hodgkin's lymphoma * Complete or partial response to first-line induction therapy with chemotherapy with rituximab * Participants about to receive first-line rituximab maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label
Exclusion criteria
* Pregnant or lactating women * Receipt of an investigational drug within 30 days prior to initiation of observational drug * Any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent * Central nervous system involvement * Hepatitis B or C virus infection or human immunodeficiency virus infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events | Baseline up to approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma | Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]) |
| Time to Next Anti-Lymphoma Treatment (TTNLT) | Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years) |
| Time to Next Chemotherapy Treatment (TTNCT) | Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years) |
| Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma | Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]) |
| Event-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma | Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]) |
| Percentage of Participants with Overall Response of Complete (CR/CRu) or Partial Response, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma | Baseline up to disease progression or death (assessed at baseline and every 8 weeks thereafter until disease progression or death [till the end of rituximab maintenance therapy, up to 2 years]) |
| Overall Survival | Baseline up to death (up to approximately 3 years) |
Countries
North Macedonia
Outcome results
None listed