Your session is about to expire
← Back to Search
Immunosuppressant
Abatacept for Graft-versus-Host Disease
Phase 1
Waitlist Available
Led By Jacalyn Rosenblatt, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is for people with chronic Graft versus Host Disease that has not responded to standard treatment with steroids. The purpose is to see if the drug abatacept is safe and if it can help control the disease better. Blood will be drawn every two weeks to check blood counts, kidney and liver function, and measure the immune system.
Who is the study for?
This trial is for adults over 18 with chronic Graft versus Host Disease (cGVHD) that hasn't improved with steroids. They must have used prednisone or equivalent for at least 4 weeks and be on a stable regimen of immunosuppressants. Participants need functioning kidneys and liver, not be pregnant or breastfeeding, use contraception if necessary, and have no serious medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The study tests abatacept, an immune system-suppressing drug approved for certain arthritis types but experimental for cGVHD. It aims to see if it's safe in cGVHD patients and helps control their condition better. The trial has two phases: first using a low dose of abatacept; if safe, then a higher dose will be tested.See study design
What are the potential side effects?
Abatacept may cause side effects due to its immune suppression function which can increase infection risk. Other potential side effects include reactions at the infusion site, headaches, nausea, or possible worsening of underlying conditions due to altered immune response.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of the Maximum Tolerated Dose (among two dose levels) and toxicity profile of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD.
Secondary outcome measures
Determination of the efficacy (in terms of cGVHD symptoms, score and steroid dose) of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD
Examination of the immunologic effects associated with the administration of abatacept in patients with steroid refractory cGVHD.
Side 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
Trial Design
1Treatment groups
Experimental Treatment
Group I: AbataceptExperimental Treatment1 Intervention
Abatacept will be administered for a total of 6 doses. Doses 1-3 will be administered at two week intervals (+/-2 days). One month following Dose 3, abatacept will be administered, and given at four-week intervals (+/-2 days) for three doses (Doses 4-6.) Patients will be followed for toxicity for 28 days following last dose of Abatacept. Patients will then be seen monthly for six months.
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?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,174 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,444 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,892 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have chronic GVHD that hasn't improved despite taking prednisone for at least 4 weeks in the past year.You have a serious medical condition, abnormal lab results, or mental health or social challenges that would make it difficult for you to understand and follow the study rules.You have received a specific type of cell infusion within the last 100 days.You have used certain medications for chronic graft-versus-host disease within the last 6 months before starting abatacept treatment.Participants must have chronic graft-versus-host disease (cGVHD) as defined by specific guidelines from the National Institutes of Health.You have taken TNF alpha inhibitors in the last four weeks before the study.You have cancer that has come back or another type of active cancer, except for certain types of skin cancer or early stage cervical or breast cancer.You have taken immunosuppressive medication or ECP within 28 days before starting treatment with abatacept.Your blood test results for neutrophils, creatinine, liver function, and tuberculosis tests must fall within specific ranges.You have a current, uncontrolled infection. If you are on long-term treatment to manage an infection, you may still be eligible.You received a live vaccine within the last four weeks before starting abatacept.You have either widespread or limited chronic graft-versus-host disease (cGVHD) that needs treatment throughout your body.Women who have not had a period for at least 12 months, or have irregular periods, and have a certain hormone level, or are taking hormone replacement therapy.You have received a bone marrow or stem cell transplant with strong or moderate conditioning treatments.You must have had a transplant or a lymphocyte infusion at least 100 days ago.You are able to perform daily activities without help, with some limitations.You are currently taking more than 1 mg of prednisone per kilogram of body weight each day.You have HIV, hepatitis B, or hepatitis C.You have received chemotherapy or radiation treatment in the past 4 weeks (6 weeks for specific types of chemotherapy) and have not fully recovered from any side effects.You are expected to live for more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: 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 is the common application of Abatacept?
"Abatacept is frequently employed to battle rheumatoid arthritis. It also has been found useful in treating ailments such as psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."
Answered by AI
Is the research team currently taking on any participants for this trial?
"According to clinicaltrials.gov, this particular trial is no longer actively recruiting patients; the post was initially made on October 1st 2013 and last updated on January 25th 2022. However, there are still 209 other studies that need participants at present time."
Answered by AI
How many participants are currently engaged in this medical experiment?
"Unfortunately, this trial has finished its recruitment period and is no longer seeking patients. It was first introduced on the 10th of October 2013 and last updated on 25th January 2022. If you are still interested in taking part in medical studies, there 175 trials that require participants with Graft vs Host Disease while 34 others need volunteers to try out Abatacept treatments."
Answered by AI
Has Abatacept been sanctioned by the Federal Drug Administration?
"Due to the preliminary nature of Abatacept's clinical trials, our team has assigned it a safety rating of 1 on a 3 point scale. There is limited data available demonstrating its efficacy and safety at this time."
Answered by AI
What other experiments have utilized Abatacept as a drug of interest?
"Currently, 34 clinical studies involving Abatacept are in progress with 8 of them at Phase 3. Toronto, Ontario is the epicentre for most trials but other 771 locations have been identified as conducting research on this medication."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger