Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)

Stopped early · Phase 3

Conditions studied: Sickle Cell Anemia

In brief

The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.

Key facts

Study ID

NCT01531387

Run by

Children's Hospital Medical Center, Cincinnati

People needed

38

Starts

2012-05-01

Expected to finish

2014-01-01

Last updated by the study team

2016-02-08

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric subjects with severe forms of sickle cell anemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab)
• Age: ≥ 2 and < 11 years of age, at the time of enrollment
• Conditional TCD Velocity (170 - 199cm/sec) by Transcranial Doppler ultrasonography examination within 3 months of enrollment
• Parent or guardian willing and able to provide informed consent
• Ability to comply with study related treatments, evaluations, and follow-up

You may not qualify if…

• Prior abnormal TCD Velocity
• History of clinical stroke
• Inability to take or tolerate daily oral hydroxyurea, including
• Known allergy to hydroxyurea therapy
• Known positive serology to HIV infection
• Known malignancy
• Current lactation
• Abnormal laboratory values at initial evaluation (temporary exclusions):
• Hemoglobin concentration < 6.0 gm/dL
• Absolute reticulocyte count < 100 x 10\^9/L with a hemoglobin concentration < 8.0 gm/dL
• WBC count < 3.0 x 10\^9/L
• Absolute neutrophil count (ANC) < 1.0 x 10\^9/L
• Platelet count < 100 x 10\^9/L
• Current use of therapeutic agents for sickle cell disease (e.g., hydroxyurea, arginine, decitabine, magnesium, chronic transfusions). Subjects must be off therapeutic agents for sickle cell disease for at least 3 months prior to enrollment.
• Current participation in other therapeutic clinical trials
• Serum creatinine more than twice the upper limit for age OR ≥ 1.0 mg/dL
• Any condition or chronic illness, which in the opinion of the clinical investigator makes participation ill-advised
• Pregnancy (for post-menarchal females only)
• Erythrocyte transfusion within the past 2 months
• Previous stem cell transplant or other myelosuppressive therapy

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti (HEMORIO) — Centro, Rio de Janeiro, Brazil
• Tropical Medicine Research Institute, University of the West Indies (UWI) — Mona, Kingston, Jamaica

Full record on ClinicalTrials.gov

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