Evidence map›Paper›PMID 34043428›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Venetoclax Combined With FLAG-IDA Induction and Consolidation in Newly Diagnosed and Relapsed or Refractory Acute Myeloid Leukemia.

Courtney D DiNardo, Curtis A Lachowiez, Koichi Takahashi, Sanam Loghavi, Lianchun Xiao, Tapan Kadia, Naval Daver, Maria Adeoti, Nicholas J Short, Koji Sasaki and 17 more

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 183 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
183citing papers in PubMed, 1 pooled it
36.3field-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.

NCT05628623 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Eradicating Measurable Residual Disease in Patients With Acute Myeloid Leukemia (AML) Prior to StEm Cell Transplantation (ERASE): A MyeloMATCH Treatment Trial

TypeinterventionalSponsorEastern Cooperative Oncology GroupRan2024 to 2027Enrolled184ConditionsLeukemia, Myeloid, AcuteArmsCytarabine, Venetoclax, CPX-351, Azacitidine
NCT05893472 phase1 / phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

The Second Affiliated Hospital of Kunming Medical University

TypeinterventionalSponsorZePing ZhouRan2023 to 2024Enrolled45ConditionsAcute Myeloid Leukemia, VenetoclaxArmscombination of venetoclax and HAA regimen
NCT05949762 phase1 / phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

The Second Affiliated Hospital of Kunming Medical University

TypeinterventionalSponsorZePing ZhouRan2023 to 2024Enrolled45ConditionsAcute Myeloid LeukemiaArmsVenetoclax in Combination With Azacitidine and HA Regimen
NCT06073730 phase3unknown statusnot on this mapstarted 2023, after this paper: background citation

Department of Hematology, The Second Affiliated Hospital of Kunming Medical University.

TypeinterventionalSponsorThe Second Affiliated Hospital of Kunming Medical UniversityRan2023 to 2025Enrolled154ConditionsElderly AML Patients, Unfit, New-diagnosis AML, Acute Myeloid Leukemia, VenetoclaxArmsExperimental: Venetoclax in combination with Decitabine (+-sorafenib), Active Comparator: Standard dose of Venetoclax + Azacitidine
3 · Its place in the literature

Who cites it

183 citing papers in PubMed, 1 synthesis or guideline pooled it, 324 citations in OpenAlex.

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  15. 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
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123 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

27 authors at 1 institution in 1 country.

Courtney D DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-9003-0390
Curtis A LachowiezDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-8506-0624
Koichi TakahashiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-8027-9659
Sanam LoghaviDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Lianchun XiaoDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Tapan KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-9892-9832
Naval DaverDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-7103-373X
Maria AdeotiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Nicholas J ShortDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-2983-2738
Koji SasakiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-9140-0610
Sa WangDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-7679-6453
Ghayas IssaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Abhishek MaitiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-9043-538X
Yesid AlvaradoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-1652-7937
Naveen PemmarajuDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-1670-6513
Guillermo Montalban BravoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Lucia MasarovaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Musa YilmazDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-0114-8384
Michael AndreeffDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-4465-6119
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-3631-2482
Steven KornblauDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-5990-9548
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Marina Y KonoplevaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
The University of Texas MD Anderson Cancer Center · US

Funding

TRAINING FOR ACADEMIC ONCOLOGY/HEMATOLOGYT32CA009666 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Michael Davies, Courtney DiNardo · 1994 to 2026
$9.8M
NCI NIH HHS T32 CA009666
6 · The paper itself

Abstract

purposeSixty percent of newly diagnosed patients with acute myeloid leukemia (ND-AML) receiving frontline therapy attain a complete response (CR), yet 30%-40% of patients relapse. Relapsed or refractory AML (R/R-AML) remains a particularly adverse population necessitating improved therapeutic options. This phase Ib/II study evaluated the safety and efficacy of fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin combined with the B-cell lymphoma-2 inhibitor venetoclax in ND-AML and R/R-AML. MATERIALS AND

methodsThe phase IB portion (PIB) enrolled patients with R/R-AML using a 3 + 3 dose escalation and de-escalation algorithm for identification of maximum tolerated dose and dose-limiting toxicities. The phase II portion enrolled patients into two arms to evaluate response and time-to-event end points: phase IIA (PIIA): ND-AML and phase IIB (PIIB): R/R-AML.

resultsSixty-eight patients have enrolled to date (PIB, 16; PIIA, 29; PIIB, 23). Median age was 46 years (range, 20-73). Grade 3 and 4 adverse events occurring in ≥ 10% of patients included febrile neutropenia (50%), bacteremia (35%), pneumonia (28%), and sepsis (12%). The overall response rate for PIB, PIIA, and PIIB was 75%, 97%, and 70% with 75%, 90%, and 61%, respectively, achieving a composite CR. Measurable residual disease-negative composite CR was attained in 96% of ND-AML and 69% of R/R-AML patients. After a median follow-up of 12 months, median overall survival (OS) for both PII cohorts was not reached. Fifty-six percent of patients proceeded to allogeneic hematopoietic stem-cell transplantation (ND-AML, 69%; R/R-AML, 46%). In R/R-AML, allogeneic hematopoietic stem-cell transplantation resulted in a significant improvement in OS (median OS, NR; 1-year OS, 87%). One-year survival post-HSCT was 94% in ND-AML and 78% in R/R-AML.

conclusionFludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin + venetoclax represents an effective intensive treatment regimen in ND-AML and R/R-AML patients, associated with deep remissions and a high rate of transition to successful transplantation.

Indexed as

Drug Resistance, NeoplasmAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicCytarabineFemaleFollow-Up StudiesGranulocyte Colony-Stimulating FactorHematopoietic Stem Cell TransplantationHumansIdarubicinLeukemia, Myeloid, AcuteMaleMaximum Tolerated DoseMiddle AgedBridged Bicyclo Compounds, HeterocyclicCytarabinefludarabineGranulocyte Colony-Stimulating FactorIdarubicinSulfonamidesvenetoclaxVidarabine

Identifiers

PMID34043428
PMCPMC8407653
OpenAlexW3164043037

What OpenQuestion 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 OpenQuestion graph.