Clinical Outcomes of Early-progressed Follicular Lymphoma in Korea (FLPOD24)
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|ClinicalTrials.gov Identifier: NCT04048395|
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Clinical Outcomes of Early-progressed Follicular Lymphoma in Korea : A Multicenter, Retrospective Analysis|
|Actual Study Start Date :||July 8, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Follicular lymphoma arm
The analysis will involve patients diagnosed with follicular lymphoma who received induction chemotherapy and then experienced a worsening of disease within 24 months from the start date of the treatment.
- Overall survival [ Time Frame: from the date of the IRB approval until 12 month ]Overall survival is defined as the time from the diagnosis to death or last follow-up.
- Progression free survival [ Time Frame: from the date of the IRB approval until 12 month ]Progression free survival is defined as the time from diagnosis to relapse, disease progression, or last follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048395
|Contact: Wonseog Kim, Professoremail@example.com|
|Contact: Kaeun Park, CRAfirstname.lastname@example.org|
|Korea, Republic of|
|81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea||Recruiting|
|Seoul, Korea, Republic of, 06351|
|Contact: Kim Wonseog, Professor 010-9933-5823 email@example.com|
|Contact: Kaeun Park, CRA +82-70-7014-4162 firstname.lastname@example.org|
|Principal Investigator:||Wonseog Kim, Professor||Samsung Medical Center|