CAREMM-2306: Advanced Immunotherapy vs. Classical Immunotherapy

January 8, 2024 updated by: Sung-Soo Park, Seoul St. Mary's Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • Seoul St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T cell engager
Drug: Immunotherapy
Immunotherapy
Standard-of-care
Drug: Immunotherapy
Immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups
Time Frame: Time Frame: Up to 2 years
overall survival
Time Frame: Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Progression-Free Survival Periods
Time Frame: Time Frame: Up to 2 years
progression-free survival
Time Frame: Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Response Rates
Time Frame: Time Frame: Up to 2 years
response rate
Time Frame: Up to 2 years
Comparison of Healthcare Costs
Time Frame: Time Frame: Up to 2 years
costs
Time Frame: Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC23RIDI0102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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