Evidence map›Paper›PMID 33288862›Full record

Trial reportBone marrow transplantation2021

Midostaurin after allogeneic stem cell transplant in patients with FLT3-internal tandem duplication-positive acute myeloid leukemia.

Richard T Maziarz, Mark Levis, Mrinal M Patnaik, Bart L Scott, Sanjay R Mohan, Abhinav Deol, Scott D Rowley, Dennis D H Kim, Daniela Hernandez, Trivikram Rajkhowa and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01883362 (A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia), which is not on this map. Cited by 91 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 5 pooled it
10.2field-weighted citation impact, top 1% 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.

NCT01883362 phase2completednot on this map

A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2018Enrolled60ConditionsAcute Myeloid LeukemiaArmsMidostaurin, Standard of Care
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 5 syntheses or guidelines pooled it, 145 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
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  8. Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation ofJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
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  10. Review
  11. Article
  12. Review
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  19. Post-HCT maintenance therapy for AML: who, when, why, how long?Hematology. American Society of Hematology. Education Program · 2025
    Review
  20. Article

31 more citing papers are in PubMed but not listed here.

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 at 10 institutions in 2 countries.

Richard T MaziarzOregon Health & Science University, Portland, OR, USA. maziarzr@ohsu.edu.ORCID http://orcid.org/0000-0002-8184-7099
Mark LevisSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.ORCID http://orcid.org/0000-0003-0473-6982
Mrinal M PatnaikMayo Clinic, Rochester, MN, USA.ORCID http://orcid.org/0000-0001-6998-662X
Bart L ScottFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Sanjay R MohanVanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Abhinav DeolKarmanos Cancer Institute, Detroit, MI, USA.ORCID http://orcid.org/0000-0003-0947-8871
Scott D RowleyHackensack University Medical Center, Hackensack, NJ, USA.
Dennis D H KimPrincess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.
Daniela HernandezSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Trivikram RajkhowaSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Kelly HainesNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Gaetano BonifacioNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Patrice RineNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Das PurkayasthaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Hugo F FernandezMoffitt Cancer Center, Tampa, FL, USA.
Novartis (United States) · USSidney Kimmel Comprehensive Cancer Center · USFred Hutch Cancer Center · USHackensack University Medical Center · USMayo Clinic in Arizona · USMoffitt Cancer Center · USOregon Health & Science University · USThe Barbara Ann Karmanos Cancer Institute · USUniversity of Toronto · CAVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluated standard-of-care (SOC) treatment with or without midostaurin to prevent relapse following allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with acute myeloid leukemia (AML) harboring internal tandem duplication (ITD) in FLT3. Adults (aged 18-70 years) who received alloHSCT in first complete remission, had achieved hematologic recovery, and were transfusion independent were randomized to receive SOC with or without midostaurin (50 mg twice daily) continuously in twelve 4-week cycles. The primary endpoint was relapse-free survival (RFS) 18 months post-alloHSCT. Sixty patients were randomized (30/arm); 30 completed all 12 cycles (midostaurin + SOC, n = 16; SOC, n = 14). The estimated 18-month RFS (95% CI) was 89% (69-96%) in the midostaurin arm and 76% (54-88%) in the SOC arm (hazard ratio, 0.46 [95% CI, 0.12-1.86]; P = 0.27); estimated relapse rates were 11% and 24%, respectively. Inhibition of FLT3 phosphorylation to <70% of baseline (achieved by 50% of midostaurin-treated patients) was associated with improved RFS. The most common serious adverse events were diarrhea, nausea, and vomiting. Rates of graft-vs-host disease were similar between both arms (midostaurin + SOC, 70%; SOC, 73%). The addition of midostaurin maintenance therapy following alloHSCT may provide clinical benefit in some patients with FLT3-ITD AML. (ClinicalTrials.gov identifier: NCT01883362).

Indexed as

Hematopoietic Stem Cell TransplantationLeukemia, Myeloid, AcuteAdolescentAdultAgedfms-Like Tyrosine Kinase 3HumansMiddle AgedMutationStaurosporineStem Cell TransplantationYoung AdultFLT3 protein, humanfms-Like Tyrosine Kinase 3midostaurinStaurosporine

Identifiers

PMID33288862
PMCPMC8113057
OpenAlexW3111594720

What OpenQuestion holds

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LicenceCC BY
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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.