Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT04048395
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2019-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Early-progressed Follicular Lymphoma in Korea
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Clinical Outcomes of Early-progressed Follicular Lymphoma in Korea : A Multicenter, Retrospective Analysis
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLPOD24
Brief Summary:
This retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. In patients with follicular lymphoma who experienced disease progression within 24 months after initiation of treatment, the second-line therapy, stem cell transplantation, tumor response, progression free survival, and overall survival will be analyzed.
Detailed Description:
Follicular lymphoma is the second most common non-Hodgkin's lymphoma in Western countries, but it is relatively less frequent in Asia. As a result, the prognosis and treatment status in Korean patients with follicular lymphoma have been rarely studied.
With the recent addition of monoclonal antibodies targeting CD20 into existing cytotoxic chemotherapy, the overall life expectancy of patients with follicular lymphoma has improved a lot. However, nearly 20% of these patients experience early worsening of disease within the first 24 months of treatment, followed by poor prognosis. Since patients with early relapse within 24 months usually experience worsening of disease during treatment with rituximab combined with chemotherapy or during rituximab maintenance therapy, optimal treatment for such patients is unknown, but remission induction therapy followed by stem cell transplantation, bendamustine combined with obinutuzumab, PI3K inhibitors, and lenalidomide are possible options. However, most of these drugs are limited for use in Korea, and there is little information with regard to treatment guidelines for patients with early relapsed follicular lymphoma or their treatment outcome in Korea.
This retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. This study will provide basic data for follicular lymphoma study in Korea and for future clinical trial design.
With the recent addition of monoclonal antibodies targeting CD20 into existing cytotoxic chemotherapy, the overall life expectancy of patients with follicular lymphoma has improved a lot. However, nearly 20% of these patients experience early worsening of disease within the first 24 months of treatment, followed by poor prognosis. Since patients with early relapse within 24 months usually experience worsening of disease during treatment with rituximab combined with chemotherapy or during rituximab maintenance therapy, optimal treatment for such patients is unknown, but remission induction therapy followed by stem cell transplantation, bendamustine combined with obinutuzumab, PI3K inhibitors, and lenalidomide are possible options. However, most of these drugs are limited for use in Korea, and there is little information with regard to treatment guidelines for patients with early relapsed follicular lymphoma or their treatment outcome in Korea.
This retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. This study will provide basic data for follicular lymphoma study in Korea and for future clinical trial design.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: