Clinical trial NCT01684865: An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma
Official title: Prospective, Non Interventional Study to Evaluate the Safety Profile of First- Line Rituximab Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with follicular non-Hodgkin's lymphoma receiving first-line rituximab maintenance treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 3 years
Secondary outcomes:
measure: Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
timeFrame: 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])
measure: Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
timeFrame: 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])
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
timeFrame: Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years)
measure: Time to Next Chemotherapy Treatment (TTNCT)
timeFrame: Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years)
measure: Overall Survival
timeFrame: Baseline up to death (up to approximately 3 years)
measure: Event-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
timeFrame: 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])
measure: 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
timeFrame: 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])
Other outcomes:
Locations:
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic of Hematology Skopje, Hospital Care Department
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: