Evidence map›Paper›PMID 41043099›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Sirolimus and Cyclosporine With Post-Transplant Cyclophosphamide or Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis in Unrelated Donor Hematopoietic Cell Transplantation.

Masumi Ueda Oshima, Phuong T Vo, Michael Boeckh, Michelle E Bouvier, Paul A Carpenter, Marco Mielcarek, Effie W Petersdorf, Rainer Storb, Ted Gooley, Brenda M Sandmaier

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03246906 (A Randomized Phase II Study to Compare the Net Clinical Benefit of Cyclosporine and Sirolimus Combined With MMF or Post-Transplant Cyclophosphamide as GVHD Prophylaxis After HLA-Matched or HLA-Mismatched Unrelated G-CSF Mobilized Blood Cell Transplantation Using Nonmyeloablative or Reduced Intensity Conditioning for Patients With Hematologic Malignancies), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03246906 phase2terminatednot on this map

A Randomized Phase II Study to Compare the Net Clinical Benefit of Cyclosporine and Sirolimus Combined With MMF or Post-Transplant Cyclophosphamide as GVHD Prophylaxis After HLA-Matched or HLA-Mismatched Unrelated G-CSF Mobilized Blood Cell Transplantation Using Nonmyeloablative or Reduced Intensity Conditioning for Patients With Hematologic Malignancies

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2017 to 2025Enrolled150ConditionsAcute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aggressive Non-Hodgkin Lymphoma, Chronic Lymphocytic LeukemiaArmsAllogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Cyclosporine, Mycophenolate Mofetil, Sirolimus
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
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

10 authors.

Masumi Ueda OshimaClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0003-2277-1976
Phuong T VoClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0002-0823-0244
Michael BoeckhClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.
Michelle E BouvierTranslational Science and Therapeutics Division, Fred Hutchinson Cancer Center, Seattle, WA.
Paul A CarpenterClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0002-5021-0714
Marco MielcarekClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0002-5680-8688
Effie W PetersdorfDepartment of Medicine, Division of Hematology and Oncology, University of Washington School of Medicine, Seattle, WA.ORCID 0000-0002-6454-3683
Rainer StorbClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.
Ted GooleyClinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA.
Brenda M SandmaierDepartment of Medicine, Division of Hematology and Oncology, University of Washington School of Medicine, Seattle, WA.ORCID 0000-0002-9767-9739

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Eric Collisson · 1985 to 2026
$296.4M
Project 3: Stem Cell Allografts for Lymphoid MalignanciesP01CA078902 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI SANDMAIER, BRENDA MARIE · 1999 to 2025
$46.1M
NCI NIH HHS P01 CA078902NCI NIH HHS P30 CA015704
6 · The paper itself

Abstract

purposeTo determine whether sirolimus (SIR) and cyclosporine (CSP) combined with post-transplantation cyclophosphamide (PTCy), after nonmyeloablative or reduced-intensity conditioning unrelated donor hematopoietic cell transplantation (HCT), would be more effective than SIR, CSP, and mycophenolate mofetil (MMF) in reducing the risk of chronic graft-versus-host disease (cGVHD) without increasing risk of recurrent malignancy.

methodsIn a Phase II trial of HLA-matched or mismatched unrelated donor mobilized blood HCT (ClinicalTrials.gov identifier: NCT03246906), adults with hematologic malignancies ineligible for myeloablative HCT were randomly assigned 1:1 to GVHD prophylaxis with SIR/CSP/PTCy (50 mg/kg once daily on days +3, +4) or SIR/CSP/MMF. The primary end point was 1-year chronic GVHD-free relapse-free survival (CRFS).

resultsOne hundred forty-five patients were randomly assigned and transplanted. Median follow-up among survivors was 3.0 (range, 0.6-7.0) years. Comparing PTCy-based with non-PTCy-based immunosuppression, estimated 1-year CRFS was 73% (95% CI, 61% to 82%) versus 48% (95% CI, 36% to 59%), translating into a hazard ratio (HR) for CRFS failure of 0.46 (95% CI, 0.26 to 0.79;

conclusionAfter HLA-matched or mismatched unrelated donor mobilized blood HCT, replacing MMF with PTCy, when used in combination with SIR and CSP, significantly reduced risk of cGVHD, without increasing risks of aGVHD or relapse. Thus, the combination of PTCy and SIR/CSP may have synergistic cGVHD-protective effects warranting further study.

Indexed as

CyclophosphamideCyclosporineGraft vs Host DiseaseHematologic NeoplasmsHematopoietic Stem Cell TransplantationMycophenolic AcidSirolimusAdolescentAdultAgedFemaleHumansImmunosuppressive AgentsMaleMiddle AgedTransplantation ConditioningCyclophosphamideCyclosporineImmunosuppressive AgentsMycophenolic AcidSirolimus

Identifiers

PMID41043099
PMCPMC12614434

What OpenQuestion holds

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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.