Evidence map›Paper›PMID 28494506›Full record

Trial reportAmerican journal of hematology2017

Minimal residual disease eradication with epigenetic therapy in core binding factor acute myeloid leukemia.

Brittany Knick Ragon, Naval Daver, Guillermo Garcia-Manero, Farhad Ravandi, Jorge Cortes, Tapan Kadia, Betul Oran, Maro Ohanian, Alessandra Ferrajoli, Naveen Pemmaraju and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in American journal of hematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00801489 (A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT00801489 phase2recruitingnot on this map

A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2007 to 2028Enrolled270ConditionsAcute Myeloid Leukemia With Inv(16)(p13.1q22), CBFB-MYH11, Acute Myeloid Leukemia With t(16, 16)(p13.1ArmsCytarabine, Decitabine, Filgrastim-sndz, Fludarabine Phosphate, Gemtuzumab Ozogamicin
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
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  15. MRD-directed and risk-adapted individualized stratified treatment of AML.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2023
    Article
  16. Review
  17. Review
  18. Therapy-related core binding factor acute myeloid leukemia.International journal of hematologic oncology · 2023
    Review
  19. Article
  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

12 authors at 1 institution in 1 country.

Brittany Knick RagonHematology/Oncology Fellowship, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID http://orcid.org/0000-0002-2460-0698
Naval DaverDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jorge CortesDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Tapan KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Betul OranDepartment of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Maro OhanianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Alessandra FerrajoliDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Naveen PemmarajuDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID http://orcid.org/0000-0002-1670-6513
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID http://orcid.org/0000-0002-1908-3307
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Recurrent translocations, t(8;21) or inv(16), in core binding factor acute myeloid leukemia (CBF-AML) are amenable to monitoring for minimal residual disease (MRD) with reverse transcriptase polymerase chain reaction (RTPCR). Despite a favorable prognosis, disease relapse remains the single cause of treatment failure in CBF-AML. Fusion products of these translocations recruit epigenetic silencing complexes resulting in hematopoietic maturation arrest. We hypothesized that maintenance therapy with hypomethylating agents (HMA), including decitabine (DAC) and azacitidine (AZA) after induction/consolidation, can be used for MRD elimination to ultimately prolong relapse free survival. Real-time quantitative (RTPCR) trends were reviewed in 23 patients (median age 53 years) with CBF-AML that received HMA therapy following induction/consolidation with fludarabine, cytarabine, and G-CSF (FLAG) with low dose gemtuzumab or idarubicin (NCT00801489). Of the 23 patients evaluated, 17 had a detectable RTPCR at HMA initiation. Five patients had progressive disease and a notable increase in RTPCR values over 1-2 cycles of HMA therapy. Twelve patients did not fail HMA and had a median RTPCR at HMA initiation of 0.06 (range, 0.01-0.91). Unlike the HMA failure subset, 11 of these patients had a reduction in RTPCR after the first or second cycle of HMA. Our data suggests that CBF-AML patients with low levels of RTPCR (between 0.01 and 0.05) at the conclusion of induction/consolidation chemotherapy benefit most from maintenance HMA, particularly those that have a reduction in the RTPCR within the first two cycles of HMA therapy.

Indexed as

Translocation, GeneticAdultAgedAminoglycosidesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineChromosomes, Human, Pair 21Chromosomes, Human, Pair 8DecitabineDisease-Free SurvivalEpigenesis, GeneticFemaleGemtuzumabHumansLeukemia, Myeloid, AcuteAminoglycosidesAntibodies, Monoclonal, HumanizedAzacitidineDecitabinefludarabineGemtuzumabVidarabine

Identifiers

PMID28494506
PMCPMC5779853
OpenAlexW2612869030

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.