Clinical trial NCT04048395: Clinical Outcomes of Early-progressed Follicular Lymphoma in Korea
Official title: Clinical Outcomes of Early-progressed Follicular Lymphoma in Korea : A Multicenter, Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Follicular Lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: from the date of the IRB approval until 12 month
Secondary outcomes:
measure: Progression free survival
timeFrame: from the date of the IRB approval until 12 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Study officials:
affiliation: Samsung Medical Center
name: Wonseog Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: