CAREMM-2306: Advanced Immunotherapy vs. Classical Immunotherapy

Lymphoma Clinical Trial

Official title:

A Comparative Study of Retrospective Outcomes Including Efficacy of Therapy Between Advanced Immunotherapy and Classical Immunochemotherapy in Relapsed/Refractory Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06202885
• Other study ID #: XC23RIDI0102
• Status: Active, not recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Immunotherapy
Immunotherapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Response Rates	response rate	Time Frame: Up to 2 years
Other	Comparison of Healthcare Costs	costs	Time Frame: Up to 2 years
Primary	Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups	overall survival	Time Frame: Up to 2 years
Secondary	Comparison of Progression-Free Survival Periods	progression-free survival	Time Frame: Up to 2 years