STRIDE Biorepository



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:15 - 40
Updated:5/25/2018
Start Date:March 13, 2017
End Date:October 2022
Contact:Lakshmanan Krishnamurti, MD
Email:lakshmanan.krishnamurti@emory.edu
Phone:404-785-1112

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1503 BMT CTN STRIDE Biorepository

The STRIDE Biorepository is an optional substudy available to participants in "Bone Marrow
Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN
1503) (STRIDE)".

A subset of sites for the main study "Bone Marrow Transplantation vs Standard of Care in
Patients with Severe Sickle Cell Disease (BMT CTN 1503) (STRIDE)" (NCT02766465) will also
participate in the biorepository portion of the study. The purpose of the biorepository is to
examine DNA to learn if certain genes predict who will have serious complications of sickle
cell disease. The STRIDE Biorepository is an optional substudy available to individuals
enrolled in the main study, who are at a participating site. Participants in the main study
who consent to take part in the biorepository will have blood drawn at the Baseline Visit.
This blood will be shipped to Emory University in Atlanta Georgia and stored for future
research.

Inclusion Criteria:

- Age 15.00 - 40.99 years

- Severe sickle cell disease [Hemoglobin SS (Hb SS), Hemoglobin SC (Hb SC) or Hemoglobin
SBeta thalassemia (Hb Sβ) genotype] with at least 1 of the following manifestations:

1. Clinically significant neurologic event (stroke) or any neurological deficit
lasting > 24 hours;

2. History of two or more episodes of acute chest syndrome (ACS) in the 2-year
period preceding enrollment despite the institution of supportive care measures
(i.e. asthma therapy);

3. Three or more pain crises per year in the 2-year period preceding referral
(required intravenous pain management in the outpatient or inpatient hospital
setting);

4. Administration of regular red blood cell (RBC) transfusion therapy, defined as
receiving 8 or more transfusions per year for ≥ 1 year to prevent vaso-occlusive
clinical complications (i.e. pain, stroke, and acute chest syndrome);

5. An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity ≥
2.7 m/sec.

- Adequate physical function as measured by all of the following:

1. Karnofsky/Lansky performance score > or equal to 60

2. Cardiac function: Left ventricular ejection fraction (LVEF) > 40%; or LV
shortening fraction > 26% by cardiac echocardiogram or by Multi Gated Acquisition
(MUGA) Scan

3. Pulmonary function: Pulse oximetry with a baseline O2 saturation of ≥ 85% and
diffusing capacity of the lung for carbon monoxide (DLCO) > 40% (corrected for
hemoglobin)

4. Renal function: Serum creatinine ≤ 1.5 x the upper limit of normal for age as per
local laboratory and 24 hour urine creatinine clearance >70 mL/min; or GFR > 70
mL/min/1.73 m2 by radionuclide Glomerular Filtration Rate (GFR)

5. Hepatic function: Serum conjugated (direct) bilirubin < 2x upper limit of normal
for age as per local laboratory; alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) < 5 times upper limit of normal as per local laboratory.
Patients with hyperbilirubinemia as a consequence of hyperhemolysis, or who
experience a sudden, profound change in the serum hemoglobin after a RBC
transfusion are not excluded.

Exclusion Criteria:

- Human Leukocyte Antigen (HLA) typing prior to referral (consultation with
hematopoietic cell transplantation (HCT) physician). However, if a subject has had HLA
typing with accompanying documentation that relatives were not HLA typed and that a
search of the unrelated donor registry was not performed the subject will be
considered eligible. Documentation will be reviewed and adjudicated by the Protocol
Officer or his/her designee.

- Uncontrolled bacterial, viral or fungal infection in the 6 weeks before enrollment.

- Seropositivity for HIV.

- Previous HCT.

- Participation in a clinical trial in which the patient received an investigational
drug or device must be discontinued at enrollment.

- A history of substance abuse as defined by version IV of the Diagnostic & Statistical
Manual of Mental Disorders (DSM IV).

- Demonstrated lack of compliance with prior medical care (determined by referring
physician).

- Pregnant or breast feeding females.

- Inability to receive HCT due to alloimmunization, defined as the inability to receive
packed red blood cell (pRBC) transfusion therapy.

- Unwillingness to use approved contraception method from time of biologic assignment
until discontinuation of all immunosuppressive medications if assignment at biologic
assignment would be to donor arm.

Additional Eligibility Criteria for Transplant after Biologic Assignment to the Donor Arm:

Participants assigned to the Donor Arm at the time of biologic assignment are subject to
additional transplant eligibility criteria as specified below. Additional, repeat clinical
assessments prior to transplant should be obtained in accordance with institutional
policies and standards of care in the interest of good clinical practice.

- Participants who are receiving ≥8 packed red blood cell transfusions for ≥1 year or
have received ≥20 packed red blood cell transfusions (cumulative) will undergo liver
magnetic resonance imaging (MRI) for estimation of hepatic iron content. Liver biopsy
is indicated for hepatic iron content ≥7 mg Fe/gm liver dry weight. Histological
examination must document the absence of cirrhosis, bridging fibrosis and active
hepatitis. The absence of bridging fibrosis will be determined using the histological
grading and staging scale as described by Ishak and colleagues (1995) as described in
the Manual of Operating Procedures.

- Cerebral MRI/magnetic resonance angiogram (MRA) within 30 days prior to initiation of
transplant conditioning. If there is clinical or radiologic evidence of a recent
neurologic event (such as stroke or transient ischemic attack) subjects will be
deferred for at least 6 months with repeat cerebral MRI/MRA to ensure stabilization of
the neurologic event prior to proceeding to transplantation.

- Absence of donor specific HLA antibodies

- Documentation of participant's willingness to use approved contraception method until
discontinuation of all immunosuppressive medications. This is to be documented in the
medical record corresponding with the consent conference.

- The HLA-matched donor must be medically fit to donate and willing to donate bone
marrow.
We found this trial at
39
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Ann Arbor, Michigan 48109
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Phone: 404-785-1441
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, Georgia 30303
Phone: 404-785-4389
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Augusta, Georgia 30912
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One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
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263 7th Avenue
Brooklyn, New York 11215
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101 Manning Dr
Chapel Hill, North Carolina 27599
(919) 966-4131
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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3858 Sheridan Street
Hollywood, Florida 33021
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70118
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New Orleans, Louisiana 70121
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New York, New York 10021
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
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Oakland, California 94609
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97227
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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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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