Clinical trial NCT06202885: CAREMM-2306: Advanced Immunotherapy vs. Classical Immunotherapy
Official title: A Comparative Study of Retrospective Outcomes Including Efficacy of Therapy Between Advanced Immunotherapy and Classical Immunochemotherapy in Relapsed/Refractory Lymphoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lymphoma
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 2500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for lymphoma at Catholic Yeouido St. Mary's Hospital and Seoul St. Mary's Hospital from May 2009 to June 2023

Brief summary: The goal of this retrospective study is to compare between the case cohort and control cohort.

The case cohort consists of lymphoma patients treated with novel immunotherapy regimen including Chimeric antigen receptor T cell therapy, bispecfic antibody, and/or antibody-drug conjugate.

The control cohort consists of lymphoma patients who received conventional chemotherapy as standard-of-care

The main question\[s\] it aims to answer are:

* Survival times
* Response outcomes

Detailed description: 1. Primary endpoints Comparison of survival time by treatment between two groups
2. Secondary endpoints 2.1 Comparison of progression-free survival between two groups 2.2 Comparison of response rates between two groups 2.3 Comparison of input medical costs between two groups.

2. Study subjects: Patients treated for lymphoma at Yeouido St. Mary's Hospital and Seoul St. Mary's Hospital (Both are located on Seoul, Korea) between May 2009 and June 2023.

3. Selection criteria: 3.1 Patients diagnosed with malignant lymphoma at Catholic Yeouido St. Mary's Hospital and Seoul St. Mary's Hospital between May 2009 and June 2023.

3.2 Age 19 or older. 3.3 Patients who treated with salvage chemotherapy for the relapsed/refractory lymphoma.

4. Exclusion criteria: 4.1 Patients suffering from acute leukemia. 4.2 Patients additionally diagnosed with solid cancer (colon cancer, lung cancer, stomach cancer, etc.) during treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with malignant lymphoma at Catholic Yeouido St. Mary's Hospital and Seoul St. Mary's Hospital between May 2009 and June 2023.
2. Age 19 or older.
3. Anti-cancer salvage chemotherpay for the treatment of relapsed/refractory lymphoma.

Exclusion Criteria:

1. Patients suffering from acute leukemia.
2. Patients additionally diagnosed with solid cancer (colon cancer, lung cancer, stomach cancer, etc.) during treatment.

Primary outcomes:
measure: Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups
timeFrame: Time Frame: Up to 2 years
Secondary outcomes:
measure: Comparison of Progression-Free Survival Periods
timeFrame: Time Frame: Up to 2 years
Other outcomes:
measure: Comparison of Response Rates
timeFrame: Time Frame: Up to 2 years
measure: Comparison of Healthcare Costs
timeFrame: Time Frame: Up to 2 years
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
Study officials:
References: