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Extended drug regimen may shield transplant patients from deadly immune attack

NCT ID NCT04380740

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

2 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beth Israel Deaconess Medical Center

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Philadelphia

    WITHDRAWN

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • City Of Hope National Medical Center

    ACTIVE_NOT_RECRUITING

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Emory University/Winship Cancer Center

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Massachusetts General Hospital

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Center

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33612, United States

  • Oregon Health and Sciences University

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97239, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Michigan

    ACTIVE_NOT_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • Washington University St. Louis

    WITHDRAWN

    St Louis, Missouri, 63110, United States

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