Immunotherapy in Lymphoma

Recruiting

• 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
• Interventions: Drug: CAR-T Therapy; Drug: Monoclonal antibody; Drug: Bispecific antibody; Drug: Proteasome Inhibitor; Drug: IMiD treatment; Drug: Antibody-Drug Conjugate

• Registration Number: NCT06796517
• Lead Sponsor: Sung-Soo Park

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-26
• Status Verified: 2025-01
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced immunochemotherapy	CAR-T Therapy	Relapsed/refractory high grade B cell lymphoma patients treated with either chimeric antigen receptor T cell therapy, bispecific antibody, or antibody-drug conjugate
Advanced immunochemotherapy	Bispecific antibody	Relapsed/refractory high grade B cell lymphoma patients treated with either chimeric antigen receptor T cell therapy, bispecific antibody, or antibody-drug conjugate
Classical Immunochemotherapy	Monoclonal antibody	Relapsed/refractory high grade B cell lymphoma patients treated with either proteasome inhibitor, immune modulatory drug, or monoclonal antibody.
Classical Immunochemotherapy	Proteasome Inhibitor	Relapsed/refractory high grade B cell lymphoma patients treated with either proteasome inhibitor, immune modulatory drug, or monoclonal antibody.
Classical Immunochemotherapy	IMiD treatment	Relapsed/refractory high grade B cell lymphoma patients treated with either proteasome inhibitor, immune modulatory drug, or monoclonal antibody.
Advanced immunochemotherapy	Antibody-Drug Conjugate	Relapsed/refractory high grade B cell lymphoma patients treated with either chimeric antigen receptor T cell therapy, bispecific antibody, or antibody-drug conjugate

Primary Outcome Measures

Name	Time	Method
Overall survival	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (2)

Seoul St. Mary Hospital; 🇰🇷 Seoul, Korea, Republic of

Yeoido St. Mary Hospital; 🇰🇷 Seoul, Korea, Republic of