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Immunosuppressant

Stem Cell Transplant for Sickle Cell Disease (Sickle-AID Trial)

Phase 2
Recruiting
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have sickle cell disease as defined by hemoglobin electropheresis, as follows: homozygous Hb S disease (HbSS), sickle-Hb C disease (HbSC), sickle beta-plus-thalassemia (HbS/β+), or sickle beta-null-thalassemia (HbS/βo)
Patients must be ≥ 12 months and < 19 years of age at the time of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new, less intense conditioning regimen for HSCT in pediatric patients with SCD, who currently are not eligible for the procedure due to donor restrictions.

Who is the study for?
This trial is for children with sickle cell disease aged 1 to less than 19 years who have had complications like pain crises, stroke, or organ damage despite treatment. They must be eligible for a stem cell transplant and have a related donor who doesn't match their blood type.
What is being tested?
The study tests a nonmyeloablative transplant approach using alemtuzumab (an antibody), low-dose total body irradiation, and sirolimus (for immune suppression) in pediatric patients with SCD having ABO-incompatible donors.
What are the potential side effects?
Possible side effects include reactions to alemtuzumab such as fever and rash; radiation-related nausea; and sirolimus risks like mouth sores, infections, or problems with kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have sickle cell disease, confirmed by a specific blood test.
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I am between 12 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of pure red cell aplasia (PRCA)
Secondary study objectives
Disease recurrence
Incidence and severity of acute GVHD
Incidence and severity of chronic GVHD
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-myeloablative conditioningExperimental Treatment3 Interventions
Non-myeloablative conditioning
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
FDA approved
Total Body Irradiation
2006
Completed Phase 3
~820
Sirolimus
FDA approved

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
811 Previous Clinical Trials
892,803 Total Patients Enrolled

Media Library

Alemtuzumab (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03214354 — Phase 2
Sickle Cell Disease Research Study Groups: Non-myeloablative conditioning
Sickle Cell Disease Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT03214354 — Phase 2
Alemtuzumab (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03214354 — Phase 2
~4 spots leftby Jul 2028
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