Actively Recruiting

Phase 1
Phase 2
Age: 0 - 20Years
All Genders
NCT00920972

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

Led by Washington University School of Medicine · Updated on 2026-03-25

220

Participants Needed

28

Research Sites

1565 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

S

St. Louis Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0 - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must have a non-malignant disorder, excluding thalassemia for Stratum 1
  • Patient must have thalassemia receiving 8/8 HLA-matched bone marrow or 5-8/8 HLA-matched umbilical cord blood for Stratum 2
  • Patient must have a hemoglobinopathy receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched umbilical cord blood for Stratum 3
  • Patient must have a non-malignant disorder (excluding hemoglobinopathy) receiving 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched umbilical cord blood for Stratum 4
  • Recipient age under 21 years
  • Lansky or Karnofsky performance score of 40 or higher
  • Adequate lung, kidney, liver, and other organ function as defined in the protocol
  • Negative pregnancy test
  • Adequate total nucleated cell or CD34+ stem cell dose as defined in the protocol
  • If the patient has sickle cell disease, Hemoglobin S level must be less than 30%
Not Eligible

You will not qualify if you...

  • HIV positive
  • Active invasive infection
  • Pregnancy or currently breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

Children's Hospital of Orange County

Orange, California, United States, 92868

Actively Recruiting

3

University of California

San Diego, California, United States, 92123

Actively Recruiting

4

Yale School of Medicine

New Haven, Connecticut, United States, 06510

Actively Recruiting

5

George Washington University School of Medicine

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

6

Nemours Children's Health

Jacksonville, Florida, United States, 32207

Completed

7

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

8

Miami Children's Hospital

Miami, Florida, United States, 33155

Completed

9

All Children's Hospital

St. Petersburg, Florida, United States, 33701

Completed

10

Children's Memorial Hospital

Chicago, Illinois, United States, 60614

Completed

11

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

12

Children's Hospital of New Orleans

New Orleans, Louisiana, United States, 70118

Completed

13

Children's Mercy

Kansas City, Missouri, United States, 64108

Completed

14

St. Louis University

St Louis, Missouri, United States, 63104

Actively Recruiting

15

Washington University School of Medicine (in St. Louis)

St Louis, Missouri, United States, 63110

Actively Recruiting

16

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Completed

17

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

18

University of North Carolina

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

19

Carolinas Medical Center

Charlotte, North Carolina, United States, 28232

Completed

20

Duke Children's Hospital

Durham, North Carolina, United States, 27705

Completed

21

The University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Completed

22

University of Pittsburg

Pittsburgh, Pennsylvania, United States, 15224

Completed

23

Cook Children's Hospital

Forth Worth, Texas, United States, 76104

Completed

24

Texas Transplant Institute

San Antonio, Texas, United States, 78229

Completed

25

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

26

BC Children's Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Completed

27

University of Manitoba

Winnipeg, Manitoba, Canada, MB R3E 0T4

Completed

28

University of Calgary

Calgary, Canada

Completed

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Research Team

L

Lissy Keller, CCRP

CONTACT

I

Ian Snyder, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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