Immunotherapy in Lymphoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-74
SponsorSung-Soo Park

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Advanced immunochemotherapy3 interventions
Group B: Classical Immunochemotherapy3 interventions

Trial outcomes

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.

Time frame
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

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sung-Soo Park

Lead sponsor

Seoul St. Mary's Hospital

Sponsor institution

Yeouido St. Mary's Hospital

Collaborator