Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease



Status:Active, not recruiting
Conditions:Orthopedic, Hematology
Therapuetic Areas:Hematology, Orthopedics / Podiatry
Healthy:No
Age Range:Any - 18
Updated:5/4/2018
Start Date:August 2013
End Date:March 2019

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Applying Biomarkers to Long-term Effects in Child and Adolescent Cancer Treatment (ABLE Team) - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease

Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and
contributes significantly to morbidity and mortality in hematopoietic stem cell
transplantation patients.

The research will look into identifying and validating cGVHD biological indicators
(=bio-markers) which will be evaluated whether they can predict a future development of the
disease.

The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be
present at the time of cGVHD diagnosis, will also be present at earlier time points, before
cGVHD develops.

Following validation, the bio-markers will be beneficial for finding those patients who are
in higher risk to develop cGVHD.

By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive
therapy might be applied in order to prevent or reduce the prevalence of the disease.


Inclusion Criteria:

1. Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant
disease.

2. Age 0-17.99 years at the time of transplantation.

3. Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or
double cord blood) as the graft source.

4. Any conditioning regimen with any chemotherapy / radiation therapy combination.
Haploidentical donor transplants with post-transplant cyclophosphamide are also
allowed.

5. Use of serotherapy is permitted.

6. Any graft-versus-host disease prophylaxis is permitted, including post-HSCT
cyclophosphamide.

7. If participant weighs between 0-20 kg, participant must be able to provide 15 ml of
whole blood at each time point.

8. If participant weighs over 20 kg, participant must be able to provide 1ml/kg of whole
blood, up to a maximum of 23 mL for the pre-conditioning sample and 32 mL for samples
at day +100, 6-months, 12-months, +/- the cGVHD sample.

9. Written informed consent from parents.

10. Assent from study participant when appropriate.

11. Participation on other clinical trials is acceptable.

Exclusion Criteria:

1. Autologous HSCT.

2. Patients referred to a Bone Marrow Transplant (BMT) center from a non-BMT center,
where it is anticipated (at the discretion of the center PI) that adequate follow up
according to the rules of this protocol can not be met, including the requirement for
a reassessment by the BMT center at the time of cGVHD diagnosis.

3. Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).

4. Second (or greater) allogeneic transplants (first allogeneic transplant where a
previous autologous transplant was performed is permitted).

5. Syngeneic transplants.
We found this trial at
19
sites
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Sonali Chaudhury, MD
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Principal Investigator: Michael Joyce, MD
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Eneida R. Nemecek, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Cori Abikoff, MD
New York Medical College The College was founded in 1860 by a group of New...
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Ann Arbor, Michigan 48109
Principal Investigator: Sung Choi, MD
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Birmingham, Alabama 35233
Principal Investigator: Joseph Chewning, MD
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Sureyya Savasan, MD
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Anna Pawlowska, MD
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Jackson, Mississippi 39216
Principal Investigator: Gail Megason, MD
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Jackson, MS
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Albert D Kheradpour, MD
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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New York, New York 10032
Principal Investigator: Monica Bhatia, MD
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Donald Coulter, MD
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Saint Petersburg, Florida 33701
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Salt Lake City, Utah 84132
Principal Investigator: Michael Boyer, MD
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San Francisco, California 94143
Principal Investigator: Justin Whalstrom, MD
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6 Kinderspitalgasse
Vienna, 1090
Principal Investigator: Anita Lawitschka, MD
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Wilmington, Delaware 19803
Principal Investigator: Emi Caywood, MD
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