Immunotherapy in Lymphoma

NCT ID: NCT06796517

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-26

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed/refractory High Grade B Cell Lymphoma High Grade B-cell Lymphoma Diffuse Large B Cell Lymphoma Relapsed Primary Mediastinal Large B-Cell Lymphoma Burkitt Lymphoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

CAR-T Therapy

Intervention Type DRUG

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.

Bispecific antibody

Intervention Type DRUG

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.

Antibody-Drug Conjugate

Intervention Type DRUG

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.

Monoclonal antibody

Intervention Type DRUG

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.

Proteasome Inhibitor

Intervention Type DRUG

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.

IMiD treatment

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeouido St. Mary's Hospital

OTHER

Sponsor Role collaborator

Sung-Soo Park

OTHER

Sponsor Role lead

Responsible Party

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Sung-Soo Park

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Seoul St. Mary Hospital

Seoul, , South Korea

Site Status RECRUITING

Yeoido St. Mary Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sung-Soo Park, MD. PhD.

Role: CONTACT

+82-02-2258-6754

Young-Woo Jeon, MD. PhD.

Role: CONTACT

+82-10-2691-4067

Facility Contacts

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Sung-Soo Park, MD. PhD.

Role: primary

+82-02-2258-6754

Young-Woo Jeon, MD. PhD.

Role: primary

+82-10-2691-4067

Other Identifiers

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RS-2023-00216446

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

XC24OIDI0042

Identifier Type: -

Identifier Source: org_study_id

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