Immunotherapy in Lymphoma

January 27, 2025 updated by: Sung-Soo Park

Risk Factor Analysis Study for the Efficacy Comparison Between Advanced Immunochemotherapy and Classical Immunochemotherapy: a Prospective Study for Relapsed/Refractory Lymphoma Patients

The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed/refractory high grade B cell lymophoma patients. The main question it aims to answer is:

Does advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies?

Researchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes.

Laboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St. Mary Hospital
        • Contact:
      • Seoul, Korea, Republic of, 07345
        • Recruiting
        • Yeoido St. Mary Hospital
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected from Seoul St. Mary hospital and Yeoido St. Mary hospital

Description

Inclusion Criteria:

  • Adults aged 19 to 74 years.
  • Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma
  • Patients who have received immunochemotherapy as treatment for relapsed/refractory lymphoma

Exclusion Criteria:

  • Patients who have progressed to acute leukemia
  • Patients who developed solid tumor during treatment
  • Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)

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
Advanced immunochemotherapy
Relapsed/refractory high grade B cell lymphoma patients treated with either chimeric antigen receptor T cell therapy, bispecific antibody, or antibody-drug conjugate
Drug: CAR-T Therapy
It uses the patient's own T cells, and requires a manufacturing process to modify and expand T cells before infusion. It directly targets B cell specific antigens, such as CD19 or CD20.
Drug: Bispecific antibody
It uses a dual targeting mechanism to enhance specificity and immune activation. It is an off-the-shelf treatment, and doesn't require a manufacturing process of patient cells.
Drug: Antibody-Drug Conjugate
It is a targeted therapy consisting of a monoclonal antibody linked to a cytotoxic drug. The antibody binds to a specific antigen on cancer cells, delivering the cytotoxic agent directly to the tumor, minimizing systemic toxicity.
Classical Immunochemotherapy
Relapsed/refractory high grade B cell lymphoma patients treated with either proteasome inhibitor, immune modulatory drug, or monoclonal antibody.
Drug: Monoclonal antibody
Monoclonal antibodies are lab-engineered antibodies that target specific antigens expressed on cancer cells. These commonly target CD20 (rituximab or obinutuzumab) to mediate immune destruction.
Drug: Proteasome Inhibitor
It blocks the activity of proteasomes, which role is degrading damaged proteins. This disruption induces apoptosis in cancer cells. Common agents include bortezomib and carfilzomib.
Drug: IMiD treatment
Immune modulatory drugs modulate the immune response by enhancing T-cell and NK cell activty to disrupt tumor progression. Common drugs include lenalidomide and thalidomide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months.
Survival status is assessed through periodic follow-ups and medical records. Patients lost of follow-up are censored at their last known date of contact. The endpoint is either the date of death documented in medical records or the date of the last known follow-up for patients still alive.
From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From the start of treatment or the date of study enrollment until disease progression or death from any cause, whichever comes first, assessed up to 100 months.
Disease progression is determined based on clinical, radiographic, or laboratory data, using the Lugano criteria. Patients without documented progression at the time of analysis are censored at their last assessment date.
From the start of treatment or the date of study enrollment until disease progression or death from any cause, whichever comes first, assessed up to 100 months.

Collaborators and Investigators

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

Sponsor

Sung-Soo Park

Collaborators

Yeouido 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)

June 26, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 19, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC24OIDI0042
  • RS-2023-00216446 (Other Grant/Funding Number: Ministry of Food and Drug Safety)

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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