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NCT Number: NCT06796517

Immunotherapy in Lymphoma

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.

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Key information

Conditions

Relapsed/refractory High Grade B Cell Lymphoma Burkitt Lymphoma DNA Virus Infections Diffuse Large B Cell Lymphoma Relapsed Disease Attributes Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections High Grade B-Cell Lymphoma Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Mediastinal Large B-Cell Lymphoma Recurrence Tumor Virus Infections Virus Diseases

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul St. Mary Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

CAR-T Therapy

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

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

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.

Monoclonal antibody

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

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sung-Soo Park, MD. PhD.

CONTACT

[email protected]

+82-02-2258-6754

Young-Woo Jeon, MD. PhD.

CONTACT

[email protected]

+82-10-2691-4067

Sponsors and collaborators

Lead sponsor

Sung-Soo Park

Other

Collaborators

  • Yeouido St. Mary's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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