Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025
FDA Approval Summary: Abatacept for the Prophylaxis of Acute GVHD.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Post-Transplant Bendamustine as a Platform for Immune Modulation After Allogeneic Hematopoietic Cell Transplantation.European journal of haematology · 2026Review
- Blinatumomab bypasses CD28 blockade to sustain T-cell cytotoxicity and improve survival in a xenograft B-ALL model.Journal for immunotherapy of cancer · 2026Article
- A living therapeutic platform for localized in situ modulation of macrophage pyroptosis ameliorates GVHD while preserving GVL.Journal of nanobiotechnology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
In December 2021, the FDA approved abatacept (Orencia; Bristol Myers Squibb) in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX) as the first drug for the prophylaxis of acute GVHD (aGVHD) in adult and pediatric (2 years of age and older) patients undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele-mismatched unrelated donor (URD). Study IM101311 included a randomized (1:1), double-blind evaluation of abatacept (N = 73) versus placebo (N = 69) +CNI+MTX as aGVHD prophylaxis in patients ≥6 years undergoing an 8/8 HLA-matched URD HSCT. Overall survival and grade II-IV aGVHD-free survival at day 180 after transplantation for abatacept versus placebo showed HRs [95% confidence interval (CI)] of 0.33 (0.12-0.93) and 0.54 (0.35-0.83), respectively. A second study, IM101841, was conducted using real-world data from the Center for International Blood and Marrow Transplant Research registry for abatacept+CNI+MTX (N = 54) versus CNI+MTX (N = 162) in patients who underwent 7/8 mismatched URD HSCT. Day 180 overall survival was 98% (95% CI, 78-100) with abatacept+CNI+MTX versus 75% (95% CI, 67-82) with CNI+MTX. Serious adverse reactions included cytomegalovirus and Epstein-Barr virus reactivation. An additional study in patients 2 to <6 years of age was required as a condition of the approval.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.