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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
Sponsor:
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center

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.

Condition or disease
Follicular Lymphoma

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Patients histologically diagnosed with follicular lymphoma (ICD-10 C82.0 to C82.9)
  2. Radiologically confirmed disease progression within 24 months from the start date of an induction chemotherapy
  3. All of the following should be available for retrospective analysis.

    • Pathologic findings report
    • Medical records containing age, sex, date of diagnosis, clinical symptoms, laboratory findings, treatment methods, progression, survival, death, etc.

Exclusion Criteria:

  1. Known histologic transformation to aggressive lymphoma
  2. Follicular lymphoma grade 3B
  3. Patients whose pathologic findings report and appropriate medical records are not available

Information from the National Library of Medicine

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


Contacts
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Contact: Wonseog Kim, Professor +82-02-3410-6548 wonseog.kim@samsung.com
Contact: Kaeun Park, CRA +82-70-7014-4162 kaeun.park@samsung.com

Locations
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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    wonseog.kim@samsung.com   
Contact: Kaeun Park, CRA    +82-70-7014-4162    kaeun.park@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Wonseog Kim, Professor Samsung Medical Center

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Responsible Party: Won Seog Kim, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04048395     History of Changes
Other Study ID Numbers: 2019-04-027
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin