Other Clinical Trial - Pembro Plus CAR T-cell Therapy in R/R in PMBCL

Status Recruiting

Clinical Trial Summary

This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment. The names of the study drugs involved in this study are: - Pembrolizumab Standard treatment will include: - CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel) - Cyclophosphamide - Fludarabine

Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The names of the study drugs involved in this study are: - Pembrolizumab Standard treatment will include: - CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel) - Cyclophosphamide - Fludarabine Participants will receive study treatment for up to 2 years and will be followed for 5 years. It is expected that about 35 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for this specific disease after two or more lines of therapy, but not in combination with CAR T-cell therapy. The CAR T-cell therapies to be used in this study are axicabtagene-ciloleucel and lisocabtagene maraleucel. The U.S. FDA has approved axicabtageneciloleucel and lisocabtagene maraleucel as treatment options for this disease, but not in combination with pembrolizumab. A small subset of patients with T-cell histiocyte-rich large B-cell lymphoma and EBV+ large B-cell lymphoma will also be included. ;

Study Design

Related Conditions & MeSH terms

Epstein-Barr Virus Infections
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Primary Mediastinal Large B Cell Lymphoma
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Clinical Trial Details

NCT number	NCT05934448
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Megan f Forsyth
Phone	857-215-1405
Email	megan_forsyth@dfci.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	November 15, 2023
Completion date	June 6, 2031

View Details

See also
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Recruiting	`NCT06026319` - CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma	Phase 1
Active, not recruiting	`NCT05162170` - Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study
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Active, not recruiting	`NCT04875195` - A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)	Phase 2
Active, not recruiting	`NCT03625037` - First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma	Phase 1/Phase 2
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Not yet recruiting	`NCT04600947` - Study of LP002 for the Treatment of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma	Phase 2
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.