Evidence map›Paper›PMID 31212080›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2019

A Phase II Multicenter Study of the Addition of Azacitidine to Reduced-Intensity Conditioning Allogeneic Transplant for High-Risk Myelodysplasia (and Older Patients with Acute Myeloid Leukemia): Results of CALGB 100801 (Alliance).

Ravi Vij, Jennifer Le-Rademacher, Kristina Laumann, Vera Hars, Kouros Owzar, Tsiporah Shore, Sumithira Vasu, Amanda Cashen, Luis Isola, Thomas Shea and 5 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Approaches to optimize outcomes in transplant recipients.Hematology. American Society of Hematology. Education Program · 2023
    Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Observational
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

15 authors.

Ravi VijDivision of Medical Oncology, Washington University School of Medicine, St. Louis, Missouri. Electronic address: rvij@wustl.edu.
Jennifer Le-RademacherAlliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Kristina LaumannAlliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Vera HarsAlliance Statistics and Data Center, Duke University, Durham, North Carolina.
Kouros OwzarAlliance Statistics and Data Center, Duke University, Durham, North Carolina.
Tsiporah ShoreDivision of Hematology/Medical Oncology, Weill Medical College of Cornell University, New York, New York.
Sumithira VasuDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Amanda CashenDivision of Medical Oncology, Washington University School of Medicine, St. Louis, Missouri.
Luis IsolaHematology and Oncology, Mt. Sinai Hospital, New York, New York.
Thomas SheaBone Marrow Transplant and Cellular Therapy Program, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.
Margarida DeMagalhaes-SilvermanBlood and Marrow Transplant Program, University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa.
David HurdHematology and Oncology, Wake Forest University Health Sciences, Winston-Salem, North Carolina.
Kenneth MeehanBlood and Marrow Transplant Program, Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, Lebanon, New Hampshire.
Frank BeardellHematology and Oncology, Christiana Care Health System, Newark, Delaware.
Steven DevineDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Delaware Christiana Care NCORPUG1CA189819 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GREGORY A MASTERS · 2014 to 2026
$21.6M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
OSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8M
UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
NCTN Lead Academic Participating Sites ApplicationU10CA180838 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A · 2014 to 2018
$2.8M
Dartmouth Lead Participation in NCI National Clinical Trials NetworkU10CA180854 · NCI · DARTMOUTH-HITCHCOCK CLINIC · PI DRAGNEV, KONSTANTIN H. · 2014 to 2018
$1.8M
Data commons for 'omic, microscopy and analysis core facilitiesS10OD018164 · OD · DUKE UNIVERSITY · PI WRAY, GREGORY A. · 2014 to 2014
$598k
NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180838NCI NIH HHS U10 CA180850NCI NIH HHS U10 CA180854NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA189819NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA233331NCI NIH HHS UG1 CA233339NCI NIH HHS UG1 CA233373NIH HHS S10 OD018164
6 · The paper itself

Abstract

Relapse remains the major cause of death in older patients transplanted for acute myeloid leukemia (AML) in first complete remission or for patients with advanced myelodysplastic syndrome (MDS) at any age. Conventional myeloablative conditioning followed by allogeneic blood or marrow transplantation is associated with significantly less relapse compared with reduced-intensity conditioning when performed in younger patients with AML or MDS, but the toxicity of this approach in older patients is prohibitive. We hypothesized that pharmacokinetic targeting to optimize busulfan (BU) exposure, combined with the administration of azacitidine (AZA) post-transplant would mitigate the risk of relapse while reducing nonrelapse mortality and ultimately improve progression-free survival (PFS). On this phase II multicenter study, 63 patients (40 unrelated donors and 23 matched related donors) received a uniform conditioning regimen consisting of fludarabine i.v. (days -7 to -3), BU targeted to a daily area under the curve (AUC) of 4000 μM/min (days -6 to -3) after the administration of a 25-mg/m

Indexed as

AdultAgedAntimetabolites, AntineoplasticAzacitidineFemaleHematopoietic Stem Cell TransplantationHumansLeukemia, Myeloid, AcuteMaleMiddle AgedTransplantation ConditioningTransplantation, HomologousAntimetabolites, AntineoplasticAzacitidineAMLAzacitidineBusulfanMDSReduced-intensity conditioning

Identifiers

PMID31212080
PMCPMC6790289

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.