CAREMM-2306: Advanced Immunotherapy vs. Classical Immunotherapy

Active, not recruiting

• Conditions: Lymphoma
• Interventions: Drug: Immunotherapy

• Registration Number: NCT06202885
• Lead Sponsor: Seoul St. Mary's Hospital

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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-18
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T cell engager	Immunotherapy	-
Standard-of-care	Immunotherapy	-

Primary Outcome Measures

Name	Time	Method
Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups	Time Frame: Up to 2 years	overall survival

Secondary Outcome Measures

Name	Time	Method
Comparison of Progression-Free Survival Periods	Time Frame: Up to 2 years	progression-free survival

Trial Locations

Locations (1)

Seoul St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of