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Costimulation Blockade
Abatacept for Graft-versus-Host Disease Prevention (ASCENT Trial)
Phase 2
Recruiting
Led By John Horan, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Previous clinical stroke, as evidenced by a neurological deficit lasting longer than 24 hours, which is accompanied by radiographic evidence of ischemic brain injury and cerebral vasculopathy.
Must have one of the following diseases: Glanzmann thrombasthenia, Chronic granulomatous disease, Severe congenital neutropenia (with resistance to granulocyte colony-stimulating factor (GCSF) or chronic requirement of GCSF doses ≥10 mcg/kg), Leukocyte adhesion deficiency, Shwachman-Diamond syndrome, Diamond-Blackfan Anemia (DBA; transfusion dependent, including steroid failure or inability to wean steroids), Thalassemia major, FA, Dyskeratosis congenita, Chediak Higashi syndrome, Acquired (immune; non-inherited, non-congenital) SAA.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
ASCENT Trial Summary
This trial is testing a new way to help prevent serious side effects from stem cell transplants in children with non-malignant blood diseases.
Who is the study for?
This trial is for children and adolescents with serious non-malignant hematologic diseases who are undergoing stem cell transplantation from an unrelated donor. Participants must be aged between 0-20.99 years, depending on their condition, and have a matched or nearly matched donor. They cannot join if they have certain organ dysfunctions, HIV, uncontrolled infections, recent clinical stroke, or are pregnant.Check my eligibility
What is being tested?
The study tests whether extended use of abatacept can prevent acute and chronic graft-versus-host disease in pediatric patients receiving stem cell transplants without affecting engraftment or immune reconstitution. All participants will receive eight doses of abatacept along with standard medications tacrolimus and mycophenolate mofetil.See study design
What are the potential side effects?
While the specific side effects of abatacept in this context aren't detailed here, generally it may cause increased risk of infections due to immune system suppression, possible allergic reactions during infusion, headache, nausea, and possibly high blood pressure.
ASCENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a stroke confirmed by brain scans showing damage.
Select...
I have a rare blood disorder or immune system condition.
Select...
I have a diagnosed artery condition in my brain shown by specific tests.
Select...
I have a genetic condition that has led to severe aplastic anemia.
Select...
I have a blood disorder that has led to 3 hospital stays due to infection in the last 3 years.
Select...
I've had 3 or more painful episodes a year needing strong pain relief before starting hydroxyurea.
Select...
I have a donor match for a bone marrow or stem cell transplant.
Select...
I have had 3 or more acute chest syndrome events requiring blood transfusions.
Select...
I need monthly blood transfusions due to a hereditary or congenital red blood cell disorder.
Select...
I am between 3-20 years old with sickle cell disease or under 21 years old with another disease.
Select...
I have a blood platelet disorder and have had over 10 transfusions in the last 3 years.
Select...
My sickle cell disease is severe, meeting at least one specific criterion.
Select...
I am not pregnant and will use birth control during the study.
ASCENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival
Secondary outcome measures
Acute GVHD
CMV Invasive Disease
Chronic GVHD
+12 moreSide effects data
From 2023 Phase 3 trial • 613 Patients • NCT030863436%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg
ASCENT Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants Receiving AbataceptExperimental Treatment1 Intervention
Pediatric participants who are undergoing URD HSCT for serious NMHD will receive 8 doses of abatacept in addition to conventional GVHD prophylaxis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112150
Find a Location
Who is running the clinical trial?
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,344 Total Patients Enrolled
Sickle Cell Transplant Advocacy & Research Alliance (STAR)UNKNOWN
Aflac Cancer and Blood Disorders CenterUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed artery condition in my brain shown by specific tests.I have had a stroke confirmed by brain scans showing damage.I have a rare blood disorder or immune system condition.My lung function is significantly reduced, below 40% of what is expected.I have a genetic condition that has led to severe aplastic anemia.I do not have any ongoing serious infections.I have not had a stroke in the last 6 months.I have a blood disorder that has led to 3 hospital stays due to infection in the last 3 years.My heart's pumping ability is significantly reduced.I have a donor for my treatment, but tests show I have antibodies against the donor's HLA.I've had 3 or more painful episodes a year needing strong pain relief before starting hydroxyurea.I have a brain condition that doesn't cause symptoms.I am HIV positive.I have a donor match for a bone marrow or stem cell transplant.I have had 3 or more acute chest syndrome events requiring blood transfusions.I need monthly blood transfusions due to a hereditary or congenital red blood cell disorder.I am between 3-20 years old with sickle cell disease or under 21 years old with another disease.I need considerable assistance and medical care.I understand the nature and risks of the HSCT process.I've had 3 or more pain or chest syndrome episodes yearly for 3 years.My kidney function is reduced with a GFR less than 60.I have severe liver scarring.I have a family member who is a perfect match for my transplant.I have a blood platelet disorder and have had over 10 transfusions in the last 3 years.My sickle cell disease is severe, meeting at least one specific criterion.I am not pregnant and will use birth control during the study.I have a long-term health issue that makes it hard for me to undergo a stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Participants Receiving Abatacept
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks might be associated with Abatacept use?
"Abatacept has undergone preliminary testing, leading to a safety rating of 2. At this juncture, there is not enough data to evaluate efficacy."
Answered by AI
Are there still spots available to join this trial?
"Affirmative. Clinicaltrials.gov data supports that this research trial is actively selecting volunteers, first advertised on August 22nd 2019 and updated lastly on March 16th 2022. The inquiry requires 28 volunteers from 9 different sites to join the investigation."
Answered by AI
For which ailments is Abatacept commonly prescribed?
"Abatacept is regularly used to manage rheumatoid arthritis, however it has also been found effective for treating psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."
Answered by AI
How many participants are enrolled to participate in this experiment?
"This clinical trial necessitates 28 qualified participants and can be conducted at multiple locations such as Childrens Healthcare of Atlanta in Georgia or the University of Mississippi Medical Center, Children's Centre for Cancer and Blood Disorders in Jackson."
Answered by AI
Are there any US-based medical facilities hosting this research endeavor?
"This clinical trial offers opportunities to participate in 10 different locations, namely: Childrens Healthcare of Atlanta in Atlanta, Georgia; University of Mississippi Medical Center; Children's Center for Cancer and Blood Disorders in Jackson, Mississippi; Hackensack Meridian Health in Hackensack, New jersey; alongside 6 other sites."
Answered by AI
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