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Immunomodulator

Extended vs Short-Term Abatacept Dosing for Graft-versus-Host Disease (ABA3 Trial)

Phase 2

Recruiting

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

Karnofsky performance score or Lanskey Play-Performance Scale score >/= 80.

Must be at least 2 years old and weigh 10 kg.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

ABA3 Trial Summary

This trial is testing whether an extended dosing regimen of abatacept, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will improve outcomes in patients who have received transplants from 7 of 8 HLA matched donors.

Who is the study for?

This trial is for patients at least 2 years old, weighing over 10 kg, with certain hematologic malignancies treatable by HCT and in remission. They need a partially matched unrelated donor and must not have severe psychiatric diseases, active infections, HIV, or inherited predispositions to cancer or transplant morbidities.Check my eligibility

What is being tested?

The study compares extended versus short-term dosing of Abatacept added to standard GVHD prophylaxis in patients receiving transplants from mismatched donors. It aims to determine which regimen better prevents severe acute and chronic GVHD without relapse post-transplant.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to immune system suppression such as increased risk of infection, possible infusion-related reactions, and any typical complications associated with bone marrow transplantation.

ABA3 Trial Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to carry out normal activities without assistance.

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I am at least 2 years old and weigh more than 10 kg.

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My blood cancer is in remission and can be treated with a stem cell transplant.

ABA3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS)

Secondary outcome measures

Non-relapse mortality

Relapse-Free survival

Graft-vs-Host Disease

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

ABA3 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Standard GVHD Prophylaxis + Abatacept Extended dosingExperimental Treatment1 Intervention

Standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate + 8 doses of Abatacept.

Group II: Standard GVHD Prophylaxis + Abatacept + PlaceboPlacebo Group2 Interventions

Standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate + 4 doses of Abatacept (investigational product) + 4 doses of Placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abatacept

2005

Completed Phase 4

~112150

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,570 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,639 Previous Clinical Trials

4,128,840 Total Patients Enrolled

Media Library

Abatacept (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04380740 — Phase 2

Graft-versus-Host Disease Research Study Groups: Standard GVHD Prophylaxis + Abatacept + Placebo, Standard GVHD Prophylaxis + Abatacept Extended dosing

Graft-versus-Host Disease Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT04380740 — Phase 2

Abatacept (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04380740 — Phase 2

Frequently Asked Questions

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

Have there been any reported dangers with using Abatacept?

"While Phase 2 trials don't have the same level of efficacy data as higher phases, there is some evidence that Abatacept is safe. Power rates it at a 2 on its safety scale."

Answered by AI

Does Abatacept have a history of being studied?

"As of this moment, there are 36 different on-going clinical trials for Abatacept. Out of those, 8 are in the third stage. Most of the studies taking place for Abatacept are located in Toronto, Ontario; however, there are 772 sites where these type of trials are happening."

Answered by AI

At how many different locations is this trial currently being conducted?

"The primary locations conducting this research are Cincinnati Children's Hospital, Emory University/Winship Cancer Center, and Dana-Farber Cancer Institute. Additionally, there are 8 other sites scattered throughout the states of Ohio, Georgia, and Massachusetts."

Answered by AI

Is there still room for more people in this experiment?

"The study, which is currently looking for participants, was originally posted on March 30th, 2022. The information available on clinicaltrials.gov was last updated on October 24th of the same year."

Answered by AI

For what type of ailment is abatacept most commonly used?

"Abatacept is not only indicated for the treatment of rheumatoid arthritis, but also for other inflammatory conditions such as psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."

Answered by AI

How many individuals are allowed to partake in this clinical trial?

"That is correct. The online clinicaltrials.gov registry reflects that this study is still recruiting patients as of today. It was first posted on March 30th, 2020 and has since been updated October 24th, 2020. There are 160 total participants needed between 8 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis

Leslie Kean 2022. "Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04380740.

All > Graft Vs Host Disease