Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases

Description

The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.

Conditions

Metabolic Disorders, Hematologic, Immune, or Bone Marrow Disorders, Hemoglobinopathies, Non-malignant Disorders

Study Overview

Study Details

Study overview

The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.

A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Non-Malignant Disease Using a Reduced-Intensity Preparatory Regime

Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases

Condition
Metabolic Disorders
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

San Diego

University of California, San Diego, California, United States, 92123

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06510

Washington

George Washington University School of Medicine, Washington, District of Columbia, United States, 20010

Miami

University of Miami, Miami, Florida, United States, 33136

Miami

Miami Children's Hospital, Miami, Florida, United States, 33155

Saint Petersburg

All Children's Hospital, Saint Petersburg, Florida, United States, 33701

Chicago

Children's Memorial Hospital, Chicago, Illinois, United States, 60614

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

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

  • * Recipient age \< 21 years
  • * Lansky/Karnofsky \>/= 40
  • * Adequate pulmonary, renal, liver, and other organ function as defined in protocol
  • * Negative pregnancy test
  • * Adequate total nucleated cell or CD34+ dose of product as defined in protocol
  • * If sickle cell, Hemoglobin S \<30%
  • * HIV positive
  • * Invasive infection
  • * Pregnancy/lactating

Ages Eligible for Study

to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington University School of Medicine,

Shalini Shenoy, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine (in St. Louis)

Study Record Dates

2031-12