NCT02536664

Brief Summary

It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

November 6, 2015

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

August 24, 2015

Results QC Date

October 7, 2015

Last Update Submit

March 21, 2023

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Were Alive and Free From Progressive Disease

    Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.

    2 years

Secondary Outcomes (6)

  • Median Progression Free Survival (PFS) Time

    2 years

  • Percentage of Participants Who Were Alive

    2 years

  • Median Overall Survival (OS) Time

    2 years

  • Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy

    2 years

  • Percentage of Participants With Best Overall Response

    2 years

  • +1 more secondary outcomes

Study Arms (2)

First-line Stratum

Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.

Drug: Rituximab

Relapsed/Refractory Stratum

Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.

Drug: Rituximab

Interventions

RituximabDRUG
Also known as: MabThera®
First-line StratumRelapsed/Refractory Stratum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with follicular lymphoma who are to be treated with Rituximab in the maintenance dosing period as decided by the physician

You may qualify if:

  • Age over 18 years
  • Previously untreated, relapsed or refractory CD 20-positive FL
  • Responding to rituximab containing induction therapy (complete response \[CR\] or partial response \[PR\])
  • To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
  • No ineligibility for rituximab

You may not qualify if:

  • Not Applicable (NA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Essen, 45122, Germany

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

September 1, 2015

Study Start

September 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 18, 2023

Results First Posted

November 6, 2015

Record last verified: 2023-03

Locations

DE(1)