Evidence map›Paper›PMID 32236406›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Isavuconazole as Primary Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome: An Open-label, Prospective, Phase 2 Study.

Prithviraj Bose, David McCue, Sebastian Wurster, Nathan P Wiederhold, Marina Konopleva, Tapan M Kadia, Gautam Borthakur, Farhad Ravandi, Lucia Masarova, Koichi Takahashi and 13 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03019939 (A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia), which is not on this map. Cited by 37 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 5 pooled it
1.3field-weighted citation impact, top 11% 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.

NCT03019939 phase2completednot on this map

A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2017 to 2020Enrolled65ConditionsAcute Myeloid Leukemia, Myelodysplastic Syndrome, NeutropeniaArmsIsavuconazole
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 74 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Brazilian guidelines for the diagnosis and treatment of candidemia and invasive candidiasis in adults and children.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Guideline
  6. Antifungal Management in Patients with Hematological Malignancies: From Primary Prophylaxis to Empirical and Diagnosis-Driven TreatmentTurkish journal of haematology : official journal of Turkish Society of Haematology · 2026
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Recommendations on the use of azole antifungals in hematology-oncology patients.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 2 institutions in 1 country.

Prithviraj BoseDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
David McCueDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sebastian WursterDepartment of Infectious Diseases, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Nathan P WiederholdFungus Testing Laboratory, Department of Pathology and Laboratory Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Marina KonoplevaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Tapan M KadiaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Gautam BorthakurDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Farhad RavandiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Lucia MasarovaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Koichi TakahashiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Zeev EstrovDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Musa YilmazDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Naval DaverDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Naveen PemmarajuDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Kiran NaqviDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Caitlin R RauschDivision of Pharmacy, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Kayleigh R MarxDivision of Pharmacy, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Wei QiaoDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Xuelin HuangDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Carol A BivinsDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sherry A PierceDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Hagop M KantarjianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Dimitrios P KontoyiannisDepartment of Infectious Diseases, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
The University of Texas MD Anderson Cancer Center · USThe University of Texas Health Science Center at San Antonio · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

backgroundMold-active primary antifungal prophylaxis (PAP) is routinely recommended in neutropenic patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) undergoing remission-induction chemotherapy (RIC). Isavuconazole (ISAV) is an extended spectrum mold-active triazole and has superior tolerability and fewer significant drug-drug interactions compared with other triazoles.

methodsIn our investigator-initiated, phase 2 trial, treatment-naive adult patients with AML or MDS starting RIC received ISAV per the dosing recommendations in the US label until neutrophil recovery (absolute neutrophil count [ANC] ≥ 0.5 × 109/L) and attainment of complete remission, occurrence of invasive fungal infection (IFI), or for a maximum of 12 weeks. The primary endpoint was the incidence of proven/probable IFI during ISAV PAP and up to 30 days after the last dose.

resultsSixty-five of 75 enrolled patients received ISAV PAP (median age, 67 years, median ANC at enrollment, 0.72 × 109/L). Thirty-two patients (49%) received oral targeted leukemia treatments (venetoclax, FTL3 inhibitors). Including the 30-day follow-up period, probable/proven and possible IFIs were encountered in 4 (6%) and 8 patients (12%), respectively. ISAV trough serum concentrations were consistently > 1 µg/mL, showed low intraindividual variation, and were not significantly influenced by chemotherapy regimen. Tolerability of ISAV was excellent, with only 3 cases (5%) of mild to moderate elevations of liver function tests and no QTc prolongations.

conclusionsISAV is a safe and effective alternative for PAP in patients with newly diagnosed AML/MDS undergoing RIC in the era of recently approved or emerging small-molecule antileukemia therapies. CLINICAL TRIALS REGISTRATION: NCT03019939.

Indexed as

Leukemia, Myeloid, AcuteMycosesMyelodysplastic SyndromesAdultAgedAntifungal AgentsHumansNitrilesProspective StudiesPyridinesTriazolesAntifungal AgentsisavuconazoleNitrilesPyridinesTriazolesantifungal prophylaxischemotherapyinvasive fungal infectionisavuconazoleleukemia

Identifiers

PMID32236406
PMCPMC8130026
OpenAlexW3014682401

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.