Evidence map›Paper›PMID 40554429›Full record

Trial reportBlood advances2025

A prospective clinical trial of GVHD prophylaxis with posttransplant cyclophosphamide and abatacept.

Divya Koura, Kaitlyn Dykes, Aaron Goodman, Caitlin Costello, Carolyn Mulroney, James K Mangan, Tiffany N Tanaka, Edward D Ball, Ayad Hamdan, Ah-Reum Jeong and 8 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03680092 (A Randomized Phase II Trial Comparing a Calcineurin Inhibitor-free Graft-versus-host Disease Prophylaxis Regimen With Post-transplantation Cyclophosphamide and Abatacept to Standard of Care), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03680092 phase2completednot on this map

A Randomized Phase II Trial Comparing a Calcineurin Inhibitor-free Graft-versus-host Disease Prophylaxis Regimen With Post-transplantation Cyclophosphamide and Abatacept to Standard of Care

TypeinterventionalSponsorDimitrios Tzachanis, MD PhDRan2019 to 2023Enrolled43ConditionsGVHD, Hematologic NeoplasmsArmsCyclophosphamide, abatacept, Methotrexate, Tacrolimus
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Divya KouraDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Kaitlyn DykesDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.ORCID 0000-0002-1638-1755
Aaron GoodmanDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Caitlin CostelloDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Carolyn MulroneyDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
James K ManganDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Tiffany N TanakaDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.ORCID 0000-0002-7656-5249
Edward D BallDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Ayad HamdanDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Ah-Reum JeongDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
James MirochaDepartment of Medicine, Clinical and Translational Science Institute and Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA.
Qingyang ZhangDepartment of Pathology, University of California San Diego, La Jolla, CA.ORCID 0009-0004-0508-567X
Paula OgrodnikDepartment of Pediatrics, University of California San Diego, La Jolla, CA.
Kimberly McConnellDepartment of Medicine, Investigational Drug Service Pharmacy, University of California San Diego, La Jolla, CA.
Joseph J MarogeDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Michelle PadillaDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.
Gerald P MorrisDepartment of Pathology, University of California San Diego, La Jolla, CA.ORCID 0000-0002-1097-4453
Dimitrios TzachanisDivision of Blood and Marrow Transplantation, Department of Medicine, University of California San Diego, La Jolla, CA.ORCID 0000-0003-4515-4428

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractWe conducted a prospective randomized clinical trial to investigate the combination of posttransplant cyclophosphamide (PTCy) and abatacept (Aba) for graft-versus-host disease (GVHD) prophylaxis. Patients with hematologic malignancies undergoing an allogeneic transplant from an 8/8 matched related or unrelated donor were randomized 1:1 to tacrolimus and methotrexate (standard-of-care arm [SOC]) or PTCy on days +3 and +4, followed by Aba on an extended schedule: days +5, +14, and +28, and every 4 weeks up to day +168 (PTCy+Aba). All patients received peripherally collected stem cells. The primary end point was moderate and severe chronic GVHD at 1 year. Following US Food and Drug Administration approval of Aba for GVHD prophylaxis leading to change in institutional SOC, the trial was amended to enroll only on the PTCy+Aba arm. A total of 25 patients enrolled on PTCy+Aba, and 15 on SOC. The trial met its primary end point: Kaplan-Meier estimates of moderate and severe chronic GVHD were 0% on the PTCy+Aba and 65.8% on the SOC arm (P < .0001). GVHD-free, relapse-free survival (GRFS) was 62.5% on PTCy+Aba and 24.1% on SOC (P = .010). There were no treatment-related deaths on PTCy+Aba and 2 on SOC. Overall survival (PTCy+Aba, 92%; SOC, 80%; P = .28), disease-free survival (PCTy+Aba, 68%; SOC, 92.9%; P = .105), and infection rates at 1 year were similar. Grade 3/4 acute GVHD rate was 4.2% on PTCy+Aba and 21.4% on SOC (P = .092). PTCy+Aba preserved regulatory T-cell proliferation and increased CD16+CD56dim cytotoxic natural killer cells. In conclusion, PTCy+Aba is well tolerated and associated with reduced chronic GVHD and improved GRFS. This trial was registered at www.ClinicalTrials.gov as #NCT03680092.

Indexed as

AbataceptCyclophosphamideGraft vs Host DiseaseHematopoietic Stem Cell TransplantationImmunosuppressive AgentsAdultAgedFemaleHematologic NeoplasmsHumansMaleMiddle AgedProspective StudiesTransplantation, HomologousTreatment OutcomeYoung AdultAbataceptCyclophosphamideImmunosuppressive Agents

Identifiers

PMID40554429
PMCPMC12402362

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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.