Full Title
Phase 2 Study Bridging Pre-Transplant Inflammatory Dampening for Primary Immune Regulatory Disorders (BRIDGE Trial)Purpose
Primary immune regulatory disorder (PIRD) and autoinflammatory conditions are conditions of the immune system that can cause an unusual amount of inflammation. While a stem cell transplant is a standard treatment for people with a PIRD or autoinflammatory condition, the inflammation caused by these conditions can reduce the effectiveness of this treatment.
In this study, researchers are assessing treatment before transplant with emapalumab or fludarabine/dexamethasone in people with a PIRD and/or an autoinflammatory condition who are planning to have a stem cell transplant. Emapalumab or fludarabine/dexamethasone are drugs that may help reduce inflammation and enable people with a PIRD and/or an autoinflammatory condition to have a successful stem cell transplant. These drugs work by either directly blocking proteins that cause inflammation or inactivating immune cells that promote inflammation.
The medications used in this study are given intravenously (by vein). Participants will receive one of two study treatments before their stem cell transplant:
- Emapalumab
- Fludarabine and dexamethasone
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have a PIRD and/or an autoinflammatory condition and be planning to have a stem cell transplant.
- Patients must have an appropriate stem cell donor.
- This study is for people of all ages.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Joseph Oved at 646-888-3314.