Overview

Realizing Effectiveness Across Continents With Hydroxyurea (REACH)

Status:
Active, not recruiting
Trial end date:
2033-08-01
Target enrollment:
0
Participant gender:
All
Summary
REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 12 months and 10 years of age. The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
Bristol-Myers Squibb
Treatments:
Hydroxyurea
Criteria
Inclusion Criteria

1. Pediatric patients with documented sickle cell anemia (typically HbSS supported by
hemoglobin electrophoresis, complete blood count, and peripheral blood smear)

2. Age range of 1.00-9.99 years, inclusive, at the time of enrollment

3. Weight at least 10.0 kg at the time of enrollment

4. Parent or guardian willing and able to provide written informed consent, with child's
verbal assent as per local IRB/Ethics Board requirements

5. Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion Criteria

1. Known medical condition making participation ill-advised, (e.g., acute or chronic
infectious disease, HIV, or malignancy)

2. Acute or chronic severe malnutrition determined by impaired growth parameters as
defined by WHO (weight for length/height or weight-for-length/height >3 z-scores below
the median WHO growth standards, as defined in Appendix I)

3. Pre-existing severe hematological toxicity (temporary exclusions)

1. Anemia: Hb <4.0 gm/dL

2. Anemia: Hb <6.0 gm/dL with ARC <100 x 109/L

3. Reticulocytopenia: ARC <80 x 109/L with Hb <7.0 gm/dL

4. Thrombocytopenia: Platelets <80 x 109/L

5. Neutropenia: ANC <1.0 x 109/L

4. Blood transfusion within 60 days before enrollment (temporary exclusion)

5. Hydroxyurea use within 6 months before enrollment