Immune Disorder HSCT Protocol

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 26, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain immune deficiency disorders, which are conditions where the immune system does not work properly. The goal is to see if a gentler form of treatment can help patients receive healthy donor cells, which could improve their immune function and overall health. The researchers believe that by using a less intense method to suppress the patient’s immune system, they can reduce the chances of the body rejecting the donor cells.

To be eligible for this trial, participants should be 28 years old or younger and meet specific health criteria, such as having a certain level of lung and heart function. They must also have a suitable matched donor for the transplant. It’s important to note that patients with specific infections or conditions, such as HIV, cannot participate. If enrolled, participants can expect close monitoring and support throughout the treatment process, aiming to improve their immune system function while minimizing side effects from the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \</= 28 years of age
• • Performance status \>/= 40
• • DLCO \>/= 40%
• • LVEF \>/=40% or LVSF \>/=26%
• • Serum creatinine \< 2x ULN
• • Liver enzymes \</= 5x ULN
• • Negative pregnancy test
• • Suitably matched donor (6/6 matched sib UCB, 8/8 matched sib BM or PBSC, 5-6/6 matched unrelated UCB, 7-8/8 matched unrelated BM, double cord)
• Exclusion Criteria:
• • Known diagnosis of HIV I/II
• • Pregnant or breastfeeding
• • Uncontrolled invasive fungal or bacterial infections within 1 month prior to starting alemtuzumab
• • Uncontrolled viral infection within 1 week prior to starting alemtuzumab