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Immunosuppressant

Abatacept for Graft-versus-Host Disease

Phase 2
Waitlist Available
Led By Leslie Kean, MD, PhD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In 3rd or greater complete remission after a marrow or extramedullary relapse
Must be at least 6 years old and weigh 20 kg.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post transplant
Awards & highlights

Study Summary

This trial is for people who are getting a stem cell transplant for certain blood cancers.

Eligible Conditions
  • Graft-versus-Host Disease
  • Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years 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
Percentage of Participants With Cumulative Incidence of Severe aGVHD at Day +100 Post-transplant
Secondary outcome measures
A Cumulative Incidence of Serious Infection, Engraftment, Relapse, and Overall Survival Will be Computed.
Percentage of Participants With Severe (Grade III-IV) aGVHD Free Survival (GFS) up to Day +180
Rate of Severe (Grade III-IV) aGVHD (Based on Adjudicated aGVHD Events) up to Day +180

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard GVHD Prophylxis + AbataceptExperimental Treatment1 Intervention
Standard GVHD prophylaxis and abatacept (investigational product). Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
Group II: Standard GVHD Prophylxis + PlaceboPlacebo Group1 Intervention
Standard GVHD prophylaxis and placebo. Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
FDA approved

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
756 Previous Clinical Trials
5,578,978 Total Patients Enrolled
FDA Office of Orphan Products DevelopmentFED
70 Previous Clinical Trials
6,128 Total Patients Enrolled
Leslie Kean, MD, PhDPrincipal InvestigatorBoston Children's Hospital
2 Previous Clinical Trials
1,011 Total Patients Enrolled

Frequently Asked Questions

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

Abatacept is typically given to patients for what reason?

"Abatacept is a medication used to treat rheumatoid arthritis. However, it can also be taken to ameliorate the symptoms of other conditions like psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."

Answered by AI

Does the data from this study corroborate other research on Abatacept?

"Abatacept was first studied in 2007 at University of Nebraska Medical Center. Since that time, there have been 2778 completed trials. As of now, 36 studies are actively recruiting new participants-- many of these taking place in Atlanta, Georgia."

Answered by AI

Is this study taking place in many different hospitals across the state?

"Enrollment for this clinical trial is currently underway at 14 different centres, some of which are Emory University/Winship Cancer Center in Atlanta, UCSF Benioff Children's Hospital Oakland in Oakland and Children's Hospital Los Angeles in Los Angeles."

Answered by AI

How many people are being given this medication as part of the research study?

"Unfortunately, this particular study has ceased looking for new participants. The last update to the trial was on August 2nd, 2021. However, there are 668 other trials currently underway for patients with malignancies and 36 more that use Abatacept as an intervention."

Answered by AI

What have been the most serious side effects of Abatacept reported by patients?

"While Phase 2 trials are not as well studied as later phases, there is enough evidence to support the safety of Abatacept."

Answered by AI

Are people with the target condition able to enroll in this trial currently?

"Unfortunately, this study is not recruiting patients at the moment. Although, it is worth noting that there are 704 other clinical trials with open enrollments. This particular study was first posted on February 1st 2013 and received its last update August 2nd 2021."

Answered by AI
~15 spots leftby Mar 2025