Extended drug regimen may shield transplant patients from deadly immune attack
NCT ID NCT04380740
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving more doses of the drug abatacept over a longer period can better prevent graft-versus-host disease (GVHD), a serious complication where donor immune cells attack the patient's body. About 160 people receiving stem cell transplants from partially matched donors will be randomly assigned to either a standard short course or an extended course of abatacept, alongside usual medications. The goal is to see if the extended regimen improves survival without severe GVHD or relapse.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Must be at least 2 years old and weigh 10 kg. 2. Must have a willing unrelated adult donor (bone marrow or peripheral blood). Donors may have a single mismatch (i.e. be a 7/8) and this mismatch may be at the allele or antigen level; however, donors with allele level disparity should be given preference over those with antigen level disparity. Patients for whom a donor is available with disparity only in the host versus graft direction (because of recipient homozygosity), will not be eligible, since this mismatching does not increase the risk for GVHD. Centers may perform extended typing (e.g. DQB1 and DPB1) according to institutional practices and use these results in selecting donors; however, it is recommended that this extending typing be used only to select between donors who are equally well matched with the recipient at the A, B, C and DRB1. 3. All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. 4. Must have a hematologic malignancy treatable by HCT (except for those stipulated below under study Exclusion Criteria), which is in remission by standard testing (no patients in relapse will be included). 5. Patients with an inherited predisposition to leukemia or otherwise hematologic malignancies that have not been associated with predisposition to transplant morbidities or non-hematologic cancers. 6. Karnofsky performance score or Lanskey Play-Performance Scale score \>/= 80. * If the patient does not meet defined eligibility requirements, the PI/study committee must be contacted to determine eligibility. Exclusion Criteria: 1. Patients with the following hematologic malignancies will be excluded: Chronic Lymphocytic Leukemia, Myeloma and Primary Myelofibrosis. 2. Active Relapse (\>5% blasts) of their primary malignancy. 3. For patients with Acute Lymphocytic Leukemia (ALL) with pre-transplant MRD testing performed as standard practice at the treating institution, patients with MRD \>0.01% will be ineligible. 4. For patients with Acute Myeloid Leukemia (AML) with pre-transplant MRD testing as standard of practice at the treating institution, patients with any MRD status are eligible and should be enrolled at the discretion of provider. 5. For patients with MDS, those with \>5% blasts will be excluded. 6. Prior allogeneic HCT. 7. Uncontrolled viral, bacterial, fungal or protozoal infection at the time of study enrollment. 8. HIV infection. 9. Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression. 10. Prisoners or others who are compulsorily detained. 11. Any patient with a known or suspected inherited predisposition to cancer should be discussed with the study team prior to screening for eligibility. 1. Patients with a known inherited or constitutional predisposition to transplant morbidities, including, but not limited to Fanconi Anemia, Dyskeratosis Congenita, Shwachman-Diamond Syndrome and Down Syndrome will be excluded. 2. Patients with known inherited or constitutional predisposition to non-hematologic cancers including, but not limited to Li-Fraumeni syndrome, BRCA1 and BRCA2 mutations will be excluded. 12. Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, and are disease free for \<2 years. 13. Incompletely treated active tuberculosis Infection. 14. Pregnancy (positive serum b-HCG) or breastfeeding. 15. Estimated GFR of \< 50 mL/min/1.73m2. 16. Cardiac ejection fraction \< 50 (using M-Mode if assessment is done by ECHO) 17. T.bilirubin \> 2 × upper limit of normal or ALT \> 4 × upper limit of normal or unresolved veno-occlusive disease. 18. Pulmonary disease with FVC, FEV1 or DLCO parameters \<45% predicted (corrected for hemoglobin) or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen. 19. Presence of antibodies to a mismatched donor HLA antigen (please refer to Section 3.4.g). 20. Patients who have developed severe AGVHD, severe CGVHD or relapse will be excluded at the time of randomization. 21. Exclusion Criteria Prior to Randomization (prior to 5th dose of abatacept/placebo): 1. Severe allergic reaction during the first 4 doses of abatacept 2. If any clinical events occur that preclude further dosing of abatacept, those patients will be deemed ineligible for randomization
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
ACTIVE_NOT_RECRUITINGBoston, Massachusetts, 02215, United States
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Children's Healthcare of Atlanta
RECRUITINGAtlanta, Georgia, 30329, United States
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Children's Hospital of Philadelphia
WITHDRAWNPhiladelphia, Pennsylvania, 19104, United States
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Cincinnati Children's Hospital
ACTIVE_NOT_RECRUITINGCincinnati, Ohio, 45229, United States
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City Of Hope National Medical Center
ACTIVE_NOT_RECRUITINGDuarte, California, 91010, United States
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Dana-Farber Cancer Institute
ACTIVE_NOT_RECRUITINGBoston, Massachusetts, 02215, United States
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Emory University/Winship Cancer Center
ACTIVE_NOT_RECRUITINGAtlanta, Georgia, 30322, United States
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Massachusetts General Hospital
ACTIVE_NOT_RECRUITINGBoston, Massachusetts, 02114, United States
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Moffitt Cancer Center
ACTIVE_NOT_RECRUITINGTampa, Florida, 33612, United States
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Oregon Health and Sciences University
ACTIVE_NOT_RECRUITINGPortland, Oregon, 97239, United States
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University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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University of Michigan
ACTIVE_NOT_RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Rochester
RECRUITINGRochester, New York, 14642, United States
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Washington University St. Louis
WITHDRAWNSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a frailty score predict which older cancer patients survive intensive care?
- Stem cell infusions put to the test against a tough transplant complication
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children
- Can a new drug stop the Body's attack after stem cell transplants?