Immunotherapy in Lymphoma

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 19 to 74 years
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

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

Being tested

CAR-T Therapy, Bispecific antibody, Antibody-Drug Conjugate, Monoclonal antibody, Proteasome Inhibitor

Keywords

immunochemotherapy, B cell lymphoma, Relapsed, Refractory

Medical subject headings

Recurrence, Burkitt Lymphoma, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• CAR-T TherapyDrug

  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 antibodyDrug

  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 ConjugateDrug

  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 antibodyDrug

  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 InhibitorDrug

  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 treatmentDrug

  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 being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Jan 2025
2. Study start26 Jun 2024
3. Primary completionDec 2025 (estimated)
4. Study completion31 Dec 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Relapsed/refractory High Grade B Cell LymphomaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.