Open, Noninterventional Trial of MabThera in Combination With Chemotherapy (CVP, CHOP or FCM) in Patients With Relapsed/Refractory Follicular Lymphoma

Lymphoma, Follicular Clinical Trial

Official title:

Relapsed/Refractory Follicular Lymphoma - Rituximab ThErapy in Combination With ChemoTherapy (REFLECT2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472756
• Other study ID #: ML21872
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: June 15, 2015
• Start date: September 2008
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Medicines and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is the evaluation of safety and tolerability of rituximab in combination with diferrent chemotherapy regimens. Additional safety data will be gained from prolonged maintenance rituximab treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients >18 years who are diagnosed with follicular lymphoma and already received one or more treatments for follicular NHL

Exclusion Criteria:

Patients who are not eligible for rituximab treatment according to SmPC.

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Chemotherapy
The treatment received was per local practice and treatment standards and not directed per the protocol.
• Rituximab
The treatment received was per local practice and treatment standards and not directed per the protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing Adverse Events (AEs)		within 30 months	No
Secondary	Objective Response (OR) measured according to Chason Standardize Response Criteria for Non-Hodgkins Lymphomas		within 30 months	No