Evidence map›Paper›PMID 34581764›Full record

ArticleBlood advances2022

Peritransplantation ruxolitinib administration is safe and effective in patients with myelofibrosis: a pilot open-label study.

Haris Ali, Ni-Chun Tsai, Timothy Synold, Sally Mokhtari, Weimin Tsia, Joycelynne Palmer, Tracey Stiller, Monzr Al Malki, Ibrahim Aldoss, Amandeep Salhotra and 9 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02917096 (Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–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.

NCT02917096 phase1completednot on this map

Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients With Myelofibrosis

TypeinterventionalSponsorCity of Hope Medical CenterRan2016 to 2023Enrolled18ConditionsPrimary Myelofibrosis, Secondary MyelofibrosisArmsAllogeneic Hematopoietic Stem Cell Transplantation, Fludarabine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Melphalan
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Allogeneic Transplantation for Older Adults.Advances in experimental medicine and biology · 2025
    Review
  16. Review
  17. Review
  18. Article
  19. Tailoring Therapy in Older Adults With Hematologic Malignancies.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2024
    Review
  20. 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

19 authors.

Haris AliDepartment of Hematology and Hematopoietic Cell Transplantation.ORCID 0000-0002-9728-7292
Ni-Chun TsaiDepartment of Computational and Quantitative Medicine.
Timothy SynoldDepartment of Cancer Biology.
Sally MokhtariDepartment of Clinical Translational Project Development, and.
Weimin TsiaDepartment of Hematology and Hematopoietic Cell Transplantation.
Joycelynne PalmerDepartment of Computational and Quantitative Medicine.
Tracey StillerDepartment of Computational and Quantitative Medicine.
Monzr Al MalkiDepartment of Hematology and Hematopoietic Cell Transplantation.
Ibrahim AldossDepartment of Hematology and Hematopoietic Cell Transplantation.
Amandeep SalhotraDepartment of Hematology and Hematopoietic Cell Transplantation.
Syed RahmanuddinDepartment of Diagnostic Radiology, City of Hope National Medical Center, Duarte, CA.
Vinod PullarkatDepartment of Hematology and Hematopoietic Cell Transplantation.
Ji-Lian CaiDepartment of Hematology and Hematopoietic Cell Transplantation.
Anthony SteinDepartment of Hematology and Hematopoietic Cell Transplantation.
Stephen J FormanDepartment of Hematology and Hematopoietic Cell Transplantation.
Guido MarcucciDepartment of Hematology and Hematopoietic Cell Transplantation.
Matthew MeiDepartment of Hematology and Hematopoietic Cell Transplantation.
David S SnyderDepartment of Hematology and Hematopoietic Cell Transplantation.
Ryotaro NakamuraDepartment of Hematology and Hematopoietic Cell Transplantation.ORCID 0000-0002-9082-0680

Funding

Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI STANLEY R. HAMILTON · 1985 to 2026
$86.3M
NCI NIH HHS P30 CA033572
6 · The paper itself

Abstract

We report results of our prospective pilot trial evaluating safety/feasibility of peritransplantation ruxolitinib for myelofibrosis treatment. Primary objectives were to determine safety and maximum tolerated dose (MTD) of ruxolitinib. Ruxolitinib was administered at 2 dose levels (DLs) of 5 and 10 mg twice daily, with fludarabine/melphalan conditioning regimen and tacrolimus/sirolimus graft-versus-host disease (GVHD) prophylaxis. We enrolled 6 and 12 patients at DL1 and DL2, respectively. Median age at transplantation was 65 years (range, 25-73). Per Dynamic International Prognostic Scoring System, 4 patients were high and 14 intermediate risk. Peripheral blood stem cells were graft source from matched sibling (n = 5) or unrelated (n = 13) donor. At each DL, 1 patient developed dose-limiting toxicities (DLTs): grade 3 cardiac and gastrointestinal with grade 4 pulmonary DLTs in DL1, and grade 3 kidney injury in DL2. All patients achieved engraftment. Grade 2 to 4 and 3 to 4 acute GVHD cumulative incidence was 17% (95% confidence interval [CI], 6-47) and 11% (95% CI, 3-41), respectively. Cumulative incidence of 1-year chronic GVHD was 42% (95% CI, 24-74). With 22.6-month (range, 6.2-25.8) median follow-up in surviving patients, 1-year overall and progression-free survival were 77% (95% CI, 50-91) and 71% (95% CI, 44-87), respectively. Causes of death (n = 4) were cardiac arrest, GVHD, respiratory failure, and refractory GVHD of liver. Our results show peritransplantation ruxolitinib is safe and well tolerated at MTD of 10 mg twice daily and associated with dose-dependent pharmacokinetic and cytokine profile. Early efficacy data are highly promising in high-risk older patients with myelofibrosis. This trial was registered at www.clinicaltrials.gov as #NCT02917096.

Indexed as

Graft vs Host DiseasePrimary MyelofibrosisHumansNitrilesProspective StudiesPyrazolesPyrimidinesNitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID34581764
PMCPMC8905711

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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.