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Monoclonal Antibodies

Transplant Method for Sickle Cell Disease (SUN Trial)

Phase 2

Recruiting

Led By Rober Nickel, MD

Research Sponsored by Robert Nickel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Administration of regular RBC transfusions (≥8 transfusions in the previous 12 months).

- History of two or more episodes of acute chest syndrome (ACS) in lifetime.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day +30, and day +100 post transplant

Awards & highlights

SUN Trial Summary

This trial is testing a new transplant method for children with sickle cell disease that may be less toxic.

Who is the study for?

This trial is for children with Sickle Cell Disease who have had complications like stroke, frequent pain or acute chest syndrome despite treatment. They must not have severe liver, heart, kidney, lung problems or a history of certain blood reactions and should not be pregnant.Check my eligibility

What is being tested?

The study tests a transplant method using alemtuzumab (an antibody), low dose radiation, and sirolimus (an immune system regulator) in siblings with matching tissue types to treat SCD with potentially less toxicity than traditional methods.See study design

What are the potential side effects?

Possible side effects include weakened immune response leading to infection risk, potential liver issues from alemtuzumab, mouth sores or skin rashes from sirolimus, and fatigue or nausea from radiation.

SUN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received 8 or more blood transfusions in the last year.

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I have had two or more episodes of severe chest pain in my life.

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I have had two or more acute coronary syndrome episodes in the last 2 years.

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I've needed strong pain medication for sickle cell pain more than three times in the last year.

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I'm sorry, but you seem to have provided an incomplete sentence. Please provide the full criterion you would like me to rewrite.

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I have had a stroke.

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I have been hospitalized for sickle cell pain or acute chest syndrome while on hydroxyurea.

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I have had 3 or more severe pain episodes from sickle cell disease treated with strong painkillers.

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I have had two or more long-lasting erections needing urgent care.

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I've had at least two episodes where my spleen trapped blood cells, requiring transfusions or surgery.

SUN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day +30, and day +100 post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day +30, and day +100 post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and day +30, and day +100 post transplant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Acute GVHD

Secondary outcome measures

PedsQL 4.0 Measurement model for the Pediatric Quality of Life Inventory

Other outcome measures

Patient-Reported Outcomes Measurement Information System (PROMIS)

Platelet transfusion

SUN Trial Design

1Treatment groups

Experimental Treatment

Group I: SUN regimenExperimental Treatment1 Intervention

Alemtuzumab, low dose total body irradiation, Sirolimus HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus (Sickle transplant Using a Nonmyeloablative approach, "SUN") can decrease the toxicity of transplant while achieving a high cure rate for children with sickle cell disease (SCD).

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Robert NickelLead Sponsor

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,473 Total Patients Enrolled

The Children's Hospital at MontefioreOTHER

1 Previous Clinical Trials

5,000,000 Total Patients Enrolled

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03587272 — Phase 2

Sickle Cell Disease Research Study Groups: SUN regimen

Sickle Cell Disease Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT03587272 — Phase 2

Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03587272 — Phase 2

Frequently Asked Questions

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

Could I potentially qualify for participation in this experiment?

"This medical trial is currently recruiting 30 children and young adults with sickle cell anemia. To be eligible, candidates must satisfy the following criteria: a record of cerebral infarction on brain MRI (overt stroke or silent stroke ≥3 mm in one dimension visible on two planes), history of at least two episodes of acute chest syndrome (ACS), abnormal transcranial Doppler velocity (>200 cm/sec by non-imaging technique; >185 cm/sec by imaging technique) measured twice, three or more SCD pain events requiring treatment with opiate or IV pain relief medication both inpatient and outpatient settings, hospital"

Answered by AI

Are new participants currently being sought for this research endeavor?

"According to clinicaltrials.gov, this study is currently accepting participants and has been since April 17th 2018. The page was last updated on March 2nd 2022."

Answered by AI

What is the geographic scope of this clinical trial?

"This trial has 6 locations for patient recruitment, found in Calgary, Columbus and Charlotte among other cities. To lower the amount of travel needed to participate, it is advised that individuals choose a centre closest to them."

Answered by AI

What can be gleaned from prior studies of Alemtuzumab intravenously, low dose total body irradiation and Sirolimus?

"Currently, 147 investigations concerning Alemtuzumab intravenously, low dose total body irradiation, Sirolimus are being conducted. Of those ongoing trials, 16 have progressed to the third phase of clinical trial research. Although these particular studies originate from Philadelphia in Pennsylvania, there is a total of 1251 medical centres running similar examinations for this intervention."

Answered by AI

How many participants are engaging in this clinical exploration?

"This clinical experiment is searching for 30 qualified patients willing to participate. Potential candidates can find sites in Calgary, Alberta and Columbus, Ohio."

Answered by AI

Is eligibility for this research limited to those under 30 years of age?

"This medical trial's requirements for participation state that the target age range is between two and 25 years old. 197 trials are available to those below 18, while 188 are meant for those above 65."

Answered by AI

Have the FDA authorized Alemtuzumab intravenously, low dose total body irradiation, and Sirolimus for medical use?

"Alemtuzumab intravenously, low dose total body irradiation and Sirolimus have been assigned a safety rating of 2. This is based on the fact that this therapy is in its Phase 2 trial stage; there are indications of safety but no evidence has been found for efficacy yet."

Answered by AI

What medical conditions could be potentially remedied by administering Alemtuzumab intravenously, low dose total body irradiation and Sirolimus?

"Alemtuzumab intravenously, low dose total body irradiation and sirolimus are typically used for the management of immune thrombocytopenic purpura. In addition, this drug-based therapy could be beneficial to those suffering from autoimmune hemolytic anemia, organ transplantation or multiple sclerosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Minimizing Toxicity in HLA-identical Related Donor Transplantation for Children With Sickle Cell Disease

Robert Nickel 2018. "Minimizing Toxicity in HLA-identical Related Donor Transplantation for Children With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03587272.

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