Evidence map›Paper›PMID 33635333›Full record

Trial reportBlood advances2021

A phase 2 trial of GVHD prophylaxis with PTCy, sirolimus, and MMF after peripheral blood haploidentical transplantation.

Nelli Bejanyan, Joseph A Pidala, Xuefeng Wang, Ram Thapa, Taiga Nishihori, Hany Elmariah, Aleksandr Lazaryan, Farhad Khimani, Marco L Davila, Asmita Mishra and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03018223 (A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
5.0field-weighted citation impact, top 4% of its field
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.

NCT03018223 phase1completednot on this map

A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2017 to 2021Enrolled32ConditionsNon-Hodgkin's Lymphoma, Acute Leukemia in Remission, Chronic Myeloid Leukemia, Primary MyelofibrosisArmsFludarabine, Busulfan, Cyclophosphamide, Total body irradiation (TBI), Peripheral Blood Hematopoietic Cell Transplantation (HCT)
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. New age GVHD prophylaxis regimens: what works for what donor and why.Hematology. American Society of Hematology. Education Program · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Optimal GVHD Prophylaxis.Advances in experimental medicine and biology · 2025
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Article
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

22 authors at 1 institution in 1 country.

Nelli BejanyanBlood and Marrow Transplant and Cellular Immunotherapy, and.
Joseph A PidalaBlood and Marrow Transplant and Cellular Immunotherapy, and.
Xuefeng WangBiostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Ram ThapaBiostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Taiga NishihoriBlood and Marrow Transplant and Cellular Immunotherapy, and.
Hany ElmariahBlood and Marrow Transplant and Cellular Immunotherapy, and.
Aleksandr LazaryanBlood and Marrow Transplant and Cellular Immunotherapy, and.
Farhad KhimaniBlood and Marrow Transplant and Cellular Immunotherapy, and.
Marco L DavilaBlood and Marrow Transplant and Cellular Immunotherapy, and.
Asmita MishraBlood and Marrow Transplant and Cellular Immunotherapy, and.
Rawan FaramandBlood and Marrow Transplant and Cellular Immunotherapy, and.
Michael D JainBlood and Marrow Transplant and Cellular Immunotherapy, and.
Leonel OchoaBlood and Marrow Transplant and Cellular Immunotherapy, and.
Lia Elena PerezBlood and Marrow Transplant and Cellular Immunotherapy, and.
Hien LiuBlood and Marrow Transplant and Cellular Immunotherapy, and.
Melissa AlsinaBlood and Marrow Transplant and Cellular Immunotherapy, and.
Mohamed A Kharfan-DabajaBlood and Marrow Transplant and Cellular Immunotherapy, and.
Hugo FernandezBlood and Marrow Transplant and Cellular Immunotherapy, and.
Michael L NiederBlood and Marrow Transplant and Cellular Immunotherapy, and.
Frederick L LockeBlood and Marrow Transplant and Cellular Immunotherapy, and.
Claudio AnasettiBlood and Marrow Transplant and Cellular Immunotherapy, and.
Ernesto AyalaBlood and Marrow Transplant and Cellular Immunotherapy, and.
Moffitt Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The introduction of posttransplant cyclophosphamide (PTCy) made performing allogeneic hematopoietic cell transplantation (HCT) from HLA haplotype-incompatible donors possible. In a setting of PTCy and tacrolimus/mycophenolate mofetil (MMF) as a graft-versus-host disease (GVHD) prophylaxis, a peripheral blood (PB) graft source as compared with bone marrow reduces the relapse rate but increases acute GVHD (aGVHD) and chronic GVHD (cGVHD). This phase 2 trial assessed sirolimus and MMF efficacy following PTCy as a GVHD prophylaxis after PB haploidentical HCT (haplo-HCT). With 32 evaluable patients (≥18 years) enrolled, this study had 90% power to demonstrate a reduction in 100-day grade II-IV aGVHD to 20% from the historical benchmark of 40% after haplo-HCT using PTCy/tacrolimus/MMF. At a median follow-up of 16.1 months, the primary end point of the trial was met with a day-100 grade II-IV aGVHD cumulative incidence of 18.8% (95% confidence interval [CI], 7.5% to 34.0%). There were no graft-failure events and the 1-year probability of National Institutes of Health (NIH) moderate/severe cGVHD was 18.8% (95% CI, 7.4% to 34.0%), nonrelapse mortality was 18.8% (95% CI, 7.4% to 34.0%), relapse was 22.2% (95% CI, 9.6% to 38.2%), disease-free survival was 59.0% (95% CI, 44.1% to 79.0%), GVHD-free relapse-free survival was 49.6% (95% CI, 34.9% to 70.5%), and overall survival was 71.7% (95% CI, 57.7% to 89.2%) for the entire cohort. These data demonstrate that GVHD prophylaxis with sirolimus/MMF following PTCy effectively prevents grade II-IV aGVHD after PB haplo-HCT, warranting prospective comparison of sirolimus vs tacrolimus in combination with MMF following PTCy as GVHD prophylaxis after PB HCT. This trial was registered at www.clinicaltrials.gov as #NCT03018223.

Indexed as

Graft vs Host DiseaseMycophenolic AcidCyclophosphamideHumansProspective StudiesSirolimusTransplantation, HaploidenticalUnited StatesCyclophosphamideMycophenolic AcidSirolimus

Identifiers

PMID33635333
PMCPMC7948297
OpenAlexW3129772109

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.