No registrations found.
ID
Source
Brief title
Health condition
follicular lymphoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of Progression of disease within 24 months from start of second line treatment (second POD24)
Secondary outcome
Overall Survival (OS), Progression-free survival after second line therapy (second PFS), Complete response rate at 30 months (CR30) from start of second line treatment (second CR30)
Background summary
The optimal treatment strategy in patients with early progressive disease is not well known. In recent years, novel insights into the biology of FL, and especially the role of the microenvironment, have resulted in the development of multiple novel treatment modalities. These new agents may ultimately improve the outlook for patients with FL with an unfavorable course, but for the development of the optimal therapeutic strategy, knowledge on the clinical and biological determinants of early refractory FL is needed.
Study objective
NA
Study design
NA
Inclusion criteria
Patients with initial diagnosis of follicular lymphoma, refractory/relapsed/transformed after first line therapy, All stages at the time of relapse, Histological grade 1-3a at the time of initial diagnosis, Age over 18 years, Availability of clinical data, including baseline information, comorbidities, data on disease localization, laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating as requested, Diagnostic material available for review, Written informed consent.
Exclusion criteria
Age < 18 years
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7865 |
Other | Medical Ethics Review Committee of the Academic Medical Center : W18_431 |