Study Overview

Study Details

Study overview

This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.

A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Immune Function Disorders Using a Reduced Intensity Preparatory Regime

Immune Disorder HSCT Protocol

Condition
Immune Deficiency Disorders
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington University School of Medicine,

Study Record Dates

2027-03