IT Therapy for Lymphoma

This trial aims to determine if a treatment involving cytarabine (a chemotherapy drug) and hydrocortisone (a corticosteroid), administered directly into the fluid around the brain and spinal cord, can manage a side effect called ICANS. ICANS is a potential brain-related side effect of CAR T-cell therapy, used to treat non-Hodgkin lymphoma that has returned or not responded to previous treatments. The trial tests whether this approach can reduce inflammation and neurological symptoms like confusion or difficulty speaking. Individuals with non-Hodgkin lymphoma who have undergone CAR T-cell therapy and experienced these symptoms might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

A previous study used a combination of medications—cytarabine, dexamethasone, and hydrocortisone—administered directly into the spinal fluid to treat certain types of leukemia. This treatment caused some side effects, such as increased levels of pancreatic enzymes and skin rash, but these were generally manageable. Another study found that combining cytarabine and hydrocortisone improved neurological symptoms in patients.

Corticosteroids, such as dexamethasone, reduce inflammation in the brain and spinal cord. These studies suggest that the treatments tested in this trial have been used before with some success and are generally well-tolerated, despite potential side effects.

Unlike the standard treatments for lymphoma, which typically involve chemotherapy or radiation, the investigational treatments in this trial focus on using a combination of corticosteroids and cytarabine to manage neurological side effects known as ICANS after CAR T-cell therapy. Researchers are excited because this approach targets the inflammation directly in the central nervous system, potentially reducing these side effects more effectively than current methods. Additionally, the trial explores whether prophylactic use of dexamethasone can prevent these symptoms from developing in the first place, which is a proactive approach not commonly used in standard care.

This trial will compare two treatment approaches for managing ICANS, a side effect of CAR T-cell therapy. One treatment arm combines Hydrocortisone, Cytarabine, and either Dexamethasone or Methylprednisolone. Studies have shown that early treatment with injections of cytarabine and dexamethasone into the fluid around the brain and spinal cord can quickly reduce ICANS symptoms. Specifically, one study found that 11 out of 12 patients who received these injections showed symptom improvement.