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Immunosuppressant

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

Q: How perilous is Alemtuzumab for individuals?

Alemtuzumab has yet to be proven effective, hence the score of 2 on our safety scale. Nonetheless, there is existing data indicating that it may have a degree of safety.

Q: Is this experiment currently enrolling participants?

Affirmative. According to clinicaltrials.gov, this study is presently enrolling participants since its initial posting on July 5th 2017 and most recent update on May 25th 2021. A total of 12 patients are needed for the single site involved in this trial.

Q: What criteria must potential participants fulfill to be eligible for this research program?

This clinical trial seeks 12 participants aged between 1 and 19 years that have been afflicted with anemia, <a href="https://www.withpower.com/clinical-trials/sickle-cell">sickle cell</a>. The selection criteria explicitly requires the patient to suffer from one of four types of hemoglobinopathy (HbSS, HbSC, HbS/β+, or HbS/βo), have experienced more than a single vaso-occlusive crisis in their life time, demonstrate elevated transcranial Doppler velocity which makes them ineligible for hydroxyurea as per TWiTCH trial guidelines (severe vascular pathology), gone through at least one acute chest crisis or splenic sequestration episode,

Q: What medical conditions does Alemtuzumab commonly treat?

Alemtuzumab is frequently employed to address immune thrombocytopenic purpura, as well autoimmune hemolytic anemia, organ transplantation, and various forms of <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>.

Q: Have other experiments been conducted on Alemtuzumab?

Currently, 147 clinical trials involving Alemtuzumab are in progress. Out of these studies, 16 have reached Phase 3 status and are hosted across 1251 different sites with the majority being located in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>.

Q: Is this medical trial recruiting geriatric candidates?

This clinical trial requires participants to fall within the age range of 1 Year and 19. There are 215 studies specifically for minors, while 211 trials have been designed for seniors aged 65 or above.

Q: How many individuals are engaged in this research endeavor?

Affirmative. Information hosted on clinicaltrials.gov indicates that this medical trial is actively recruiting participants, with the original post date being July 5th 2017 and most recent update occurring May 25th 2021. The study requires 12 patients to be recruited from a single location.

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

Sickle-AID Trial 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.Check my eligibility

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.See study design

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.

Sickle-AID Trial 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.

Select...

I am between 12 and 18 years old.

Sickle-AID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of pure red cell aplasia (PRCA)

Secondary outcome measures

Disease recurrence

Incidence and severity of acute GVHD

Incidence and severity of chronic GVHD

+4 more

Sickle-AID 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,142 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How perilous is Alemtuzumab for individuals?

"Alemtuzumab has yet to be proven effective, hence the score of 2 on our safety scale. Nonetheless, there is existing data indicating that it may have a degree of safety."

Answered by AI

Is this experiment currently enrolling participants?

"Affirmative. According to clinicaltrials.gov, this study is presently enrolling participants since its initial posting on July 5th 2017 and most recent update on May 25th 2021. A total of 12 patients are needed for the single site involved in this trial."

Answered by AI

What criteria must potential participants fulfill to be eligible for this research program?

"This clinical trial seeks 12 participants aged between 1 and 19 years that have been afflicted with anemia, sickle cell. The selection criteria explicitly requires the patient to suffer from one of four types of hemoglobinopathy (HbSS, HbSC, HbS/β+, or HbS/βo), have experienced more than a single vaso-occlusive crisis in their life time, demonstrate elevated transcranial Doppler velocity which makes them ineligible for hydroxyurea as per TWiTCH trial guidelines (severe vascular pathology), gone through at least one acute chest crisis or splenic sequestration episode,"

Answered by AI

What medical conditions does Alemtuzumab commonly treat?

"Alemtuzumab is frequently employed to address immune thrombocytopenic purpura, as well autoimmune hemolytic anemia, organ transplantation, and various forms of multiple sclerosis."

Answered by AI

Have other experiments been conducted on Alemtuzumab?

"Currently, 147 clinical trials involving Alemtuzumab are in progress. Out of these studies, 16 have reached Phase 3 status and are hosted across 1251 different sites with the majority being located in Philadelphia, Pennsylvania."

Answered by AI

Is this medical trial recruiting geriatric candidates?

"This clinical trial requires participants to fall within the age range of 1 Year and 19. There are 215 studies specifically for minors, while 211 trials have been designed for seniors aged 65 or above."

Answered by AI

How many individuals are engaged in this research endeavor?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical trial is actively recruiting participants, with the original post date being July 5th 2017 and most recent update occurring May 25th 2021. The study requires 12 patients to be recruited from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nonmyeloablative Stem Cell Transplant in Children With Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor

Tony H. Truong 2017. "Nonmyeloablative Stem Cell Transplant in Children With Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03214354.

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