Immunotherapy in Lymphoma

NCT06796517 | Recruiting DMC FDA Drug

• 2 other identifiers: XC24OIDI0042RS-2023-00216446
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

immunochemotherapy; B cell lymphoma; Relapsed; Refractory

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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 Outcomes (1)

• Progression-free survival

  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.

Study Arms (2)

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; Drug: Bispecific antibody; Drug: Antibody-Drug Conjugate

Classical Immunochemotherapy

Relapsed/refractory high grade B cell lymphoma patients treated with either proteasome inhibitor, immune modulatory drug, or monoclonal antibody.

Drug: Monoclonal antibody; Drug: Proteasome Inhibitor; Drug: IMiD treatment

Interventions

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.

Advanced immunochemotherapy

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.

Advanced immunochemotherapy

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.

Advanced immunochemotherapy

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.

Classical Immunochemotherapy

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.

Classical Immunochemotherapy

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.

Classical Immunochemotherapy

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Sung-Soo Park: lead
• Yeouido St. Mary's Hospital: collaborator

Study Sites (2)

Seoul St. Mary Hospital

Seoul, 06591, South Korea

RECRUITING

Yeoido St. Mary Hospital

Seoul, 07345, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum, Bone marrow

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma; Lymphoma, B-Cell

Interventions

Immunotherapy, Adoptive; Antibodies, Bispecific; Immunoconjugates; Antibodies, Monoclonal; Proteasome Inhibitors

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action

Central Study Contacts

Sung-Soo Park, MD. PhD.

CONTACT

+82-02-2258-6754; sspark@catholic.ac.kr

Young-Woo Jeon, MD. PhD.

CONTACT

+82-10-2691-4067; native47@catholic.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 28, 2025
• Study Start: June 26, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)