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



Status:Recruiting
Conditions:Blood Cancer, Endocrine, Hematology
Therapuetic Areas:Endocrinology, Hematology, Oncology
Healthy:No
Age Range:Any - 20
Updated:5/9/2018
Start Date:December 2001
End Date:December 2021
Contact:Lisa Murray, MA, CCRP
Email:Murray_L@kids.wustl.edu
Phone:3144544240

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


Inclusion Criteria:

Stratum 1: Patient must have a hemoglobinopathy receiving a matched related transplant with
bone marrow or peripheral blood stem cells.

Stratum 2: Patient must have thalassemia receiving an unrelated donor transplant with bone
marrow or umbilical cord blood stem cells.

Stratum 3: Patient must have a hemoglobinopathy receiving a minimally mismatched unrelated
donor transplant with bone marrow or single or double umbilical cord blood product.

Stratum 4: Patient must have a non-malignant disorder (excluding hemoglobinopathy)
receiving a minor mismatched unrelated donor transplant with bone marrow or single or
double umbilical cord blood product.

All strata:

- 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 <45%

Exclusion Criteria:

- HIV positive

- Invasive infection

- Pregnancy/lactating
We found this trial at
18
sites
Washington University School of Medicine St. Louis
660 South Euclid Avenue
Saint Louis, Missouri 63110
Phone: 314-454-6018
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Carolinas Medical Center
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael Eckrich, MD
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Charlotte, NC
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University of Miami
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Martin Andreansky, MD
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Miami Children's Hospital
3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Principal Investigator: Kamar Godder, MD
Miami Children's Hospital Welcome to Miami Children
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Miami, FL
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Children's Memorial Hospital
Chicago, Illinois 60614
Principal Investigator: Sonali Chaudhury, MD
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Chicago, IL
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Suhag Parikh, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Hackensack University Medical Center
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Alfred Gillio, MD
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Indiana University School of Medicine
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Paul Haut, MD
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indianapolis, IN
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Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
Principal Investigator: Jignesh Dalal, MD
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Kansas City, MO
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Louisiana State University
New Orleans, Louisiana 70112
Principal Investigator: Lolie Yu, MD
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New Orleans, LA
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Columbia University Medical Center
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Monica Bhatia, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Phoenix Children's Hospital
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Roberta Adams, MD
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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St. Louis University
Saint Louis, Missouri 63110
Principal Investigator: Deepika Bhatla, MD
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Saint Louis, MO
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All Children's Hospital
Saint Petersburg, Florida 33701
Principal Investigator: Gregory Hale, MD
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Saint Petersburg, FL
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Texas Transplant Institute
San Antonio, Texas 78229
Principal Investigator: Troy Quigg, MD
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San Antonio, TX
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University of California
San Diego, California 92103
Principal Investigator: Eric Anderson, MD
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San Diego, CA
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George Washington University School of Medicine
Washington, District of Columbia 20037
Principal Investigator: David Jacobsohn, MD
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Washington,
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University of Manitoba
Winnipeg, Manitoba
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Winnipeg,
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