Evidence map›Paper›PMID 40000842›Full record

Trial reportLeukemia2025

Long term results of venetoclax combined with FLAG-IDA induction and consolidation for newly diagnosed and relapsed or refractory acute myeloid leukemia.

Courtney D DiNardo, Wei-Ying Jen, Koichi Takahashi, Tapan M Kadia, Sanam Loghavi, Naval G Daver, Lianchun Xiao, Patrick K Reville, Ghayas C Issa, Nicholas J Short and 28 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Leukemia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03214562 (A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory AML), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing 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.

NCT03214562 phase1 / phase2recruitingnot on this map

A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory AML

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2017 to 2027Enrolled116ConditionsHigh Risk Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid LeukemiaArmsCytarabine, Filgrastim, Fludarabine, Idarubicin, Pegfilgrastim
3 · Its place in the literature

Who cites it

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

  1. Pooled it
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  3. Trial
  4. Nucleolin Alterations and ROS Production Associate With Sensitivity of AML Cells to Venetoclax.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Article
  5. Pediatric AML CAR T cell therapy.Molecular therapy. Oncology · 2026
    Review
  6. Updates of CSCO guidelines for diagnosis and treatment of acute leukemia: 2026 edition.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2026
    Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors.

Courtney D DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. cdinardo@mdanderson.org.ORCID 0000-0001-9003-0390
Wei-Ying JenDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-9339-3362
Koichi TakahashiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-8027-9659
Tapan M KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-9892-9832
Sanam LoghaviDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-8980-3202
Naval G DaverDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-7103-373X
Lianchun XiaoDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Patrick K RevilleDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-8433-3360
Ghayas C IssaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-4339-8683
Nicholas J ShortDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-2983-2738
Koji SasakiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-9140-0610
Sa A WangDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-9385-9911
Jillian K MullinDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sherry PierceDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Corey BradleyDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-7679-6453
Abhishek MaitiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yesid AlvaradoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-1652-7937
Naveen PemmarajuDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-1670-6513
Alessandra FerrajoliDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mahesh SwaminathanDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-5959-397X
Maro OhanianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hussein A AbbasDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-2946-3562
Danielle HammondDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-6017-2264
Jan BurgerDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-6177-7572
Fadi HaddadDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guillermo Montalban-BravoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-4533-5176
Kelly ChienDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-6024-1613
Lucia MasarovaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Musa YilmazDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-4498-4895
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Michael AndreeffDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-3631-2482
Steven KornblauDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-5990-9548
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-7621-377X
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-4465-6119
Marina Y KonoplevaDepartment of Oncology, Montefiore Einstein Comprehensive Cancer Center, Bronx, NY, USA.ORCID 0000-0002-9347-2212
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-1908-3307

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
University of Texas M.D. Anderson Cancer SPORE-LeukemiaP50CA100632 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI REZVANI, KATY · 2003 to 2023
$43.7M
Leukemia and Lymphoma Society (Leukemia & Lymphoma Society) AWD00006066NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA100632UT | University of Texas MD Anderson Cancer Center (MD Anderson) CA100632V Foundation for Cancer Research (V Foundation) D2018 - 013
6 · The paper itself

Abstract

Intensive chemotherapy remains the standard for newly diagnosed (ND) acute myeloid leukemia (AML); however, relapse risk remains high. Additionally, most patients with relapsed/refractory (RR) AML have poor outcomes. We report the long-term experience of 138 patients, 77 ND and 61 RR, treated with FLAG-IDA in combination with venetoclax. In the ND cohort, the overall response rate (ORR) was 97%, with a composite complete remission (CRc) rate of 95% and undetectable measurable residual disease (MRD) status by flow cytometry in 90%. The 3-year OS and EFS rates were 66 and 64%, respectively. Outcomes were similar across European LeukemiaNet (ELN) 2022 risk groups. Sixty-four percent transitioned to allogeneic hematopoietic stem cell transplantation (allo-SCT) in CR1. In the RR cohort, the ORR was 67%; CRc rate 41% and flow negative MRD rate 74%; 57% transitioned to allo-SCT. The patients with RR AML in first salvage with wild-type TP53 status had particularly favorable outcomes, with an ORR of 79%, CRc rate of 74% (76% MRD undetectable) and 3-year OS rate of 51%. Infectious and hematologic adverse events were common, with low 30- and 60-day mortality similar to other intensive chemotherapy regimens. FLAG-IDA + VEN is effective for remission induction in both ND and RR AML.ClinicalTrials.gov Identifier: NCT03214562.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsConsolidation ChemotherapyDrug Resistance, NeoplasmLeukemia, Myeloid, AcuteNeoplasm Recurrence, LocalAdolescentAdultAgedBridged Bicyclo Compounds, HeterocyclicCytarabineFemaleFollow-Up StudiesHematopoietic Stem Cell TransplantationHumansIdarubicinInduction ChemotherapyBridged Bicyclo Compounds, HeterocyclicCytarabineIdarubicinSulfonamidesvenetoclax

Identifiers

PMID40000842
PMCPMC11978487

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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.