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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.
Must not have
For patients with MDS, those with >5% blasts will be excluded.
HIV infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My MDS does not have more than 5% blasts.
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I am HIV positive.
Select...
I have had a stem cell transplant from a donor.
Select...
I do not have Chronic Lymphocytic Leukemia, Myeloma, or Primary Myelofibrosis.
Select...
My leukemia has minimal residual disease above 0.01%, making me ineligible.
Select...
I have not had severe acute or chronic graft-versus-host disease, nor has my condition worsened.
Select...
My kidney function is reduced, with a GFR under 50.
Select...
I do not have genetic conditions like Fanconi Anemia or Down Syndrome.
Select...
My cancer has returned and is active.
Select...
My lung function is very low or I need extra oxygen.
Select...
I do not have genetic conditions like Li-Fraumeni syndrome or BRCA mutations.
Select...
I do not have any ongoing serious infections.
Select...
I am currently being treated for active tuberculosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS)
Secondary study objectives
Non-relapse mortality
Relapse-Free survival
Graft-vs-Host Disease
Side effects data
From 2023 Phase 3 trial • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
RASH
12%
ACUTE RESPIRATORY FAILURE
12%
WEIGHT INCREASED
12%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
OROPHARYNGEAL PAIN
12%
ARTHRALGIA
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
PATELLA FRACTURE
6%
ASTHMA
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
COSTOCHONDRITIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PHOTODERMATOSIS
6%
PNEUMONIA BACTERIAL
6%
STOMATITIS
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
SWELLING
6%
ACUTE KIDNEY INJURY
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
HERPES ZOSTER
6%
OSTEOARTHRITIS
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SKIN LACERATION
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
SEBORRHOEIC KERATOSIS
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD
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
~112250
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
785 Previous Clinical Trials
5,581,571 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,686 Previous Clinical Trials
4,129,701 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My MDS does not have more than 5% blasts.I am HIV positive.I am mostly able to carry out normal activities without assistance.I have had a stem cell transplant from a donor.I do not have Chronic Lymphocytic Leukemia, Myeloma, or Primary Myelofibrosis.My leukemia has minimal residual disease above 0.01%, making me ineligible.I may have a genetic risk for cancer and will discuss this with the study team.My kidney function is reduced, with a GFR under 50.I have a genetic risk for leukemia but not for other cancers or transplant complications.I have been cancer-free for less than 2 years, excluding non-melanoma skin cancers.I have not had severe acute or chronic graft-versus-host disease, nor has my condition worsened.I do not have genetic conditions like Fanconi Anemia or Down Syndrome.I have a willing donor who is mostly a match for me.I have AML and my doctor decides if I can join based on my MRD status.My cancer has returned and is active.I am at least 2 years old and weigh more than 10 kg.My lung function is very low or I need extra oxygen.My blood cancer is in remission and can be treated with a stem cell transplant.I do not have genetic conditions like Li-Fraumeni syndrome or BRCA mutations.I can continue taking abatacept without any health issues.I do not have any ongoing serious infections.I am currently being treated for active tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Standard GVHD Prophylaxis + Abatacept + Placebo
- Group 2: Standard GVHD Prophylaxis + Abatacept Extended dosing
Awards:
This trial has 0 awards, including: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.
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