Evidence map›Paper›PMID 38548404›Full record

Trial reportThe Lancet. Haematology2024

Reduced dose azacitidine plus venetoclax as maintenance therapy in acute myeloid leukaemia following intensive or low-intensity induction: a single-centre, single-arm, phase 2 trial.

Alexandre Bazinet, Hagop Kantarjian, Alex Bataller, Naveen Pemmaraju, Gautam Borthakur, Kelly Chien, Yesid Alvarado, Prithviraj Bose, Elias Jabbour, Musa Yilmaz and 10 more

Open access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Haematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
8.6field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 19 citations in OpenAlex.

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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

20 authors at 1 institution in 1 country.

Alexandre BazinetDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hagop KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alex BatallerDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Naveen PemmarajuDepartment 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.
Kelly ChienDepartment 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.
Prithviraj BoseDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Elias JabbourDepartment 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.
Courtney DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ghayas IssaDepartment 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.
Nicholas ShortDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Koji SasakiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Debra Bull-LindermanDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Naval DaverDepartment 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.
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Tapan KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: tkadia@mdanderson.org.
The University of Texas MD Anderson Cancer Center · US

Funding

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

Abstract

backgroundPatients with acute myeloid leukaemia have high rates of relapse, especially if they are unable to complete standard consolidation strategies or allogeneic haematopoietic stem-cell transplantation (HSCT). The phase 3 QUAZAR AML-001 study showed an overall survival benefit with oral azacitidine maintenance. The BCL2 inhibitor venetoclax is highly active in acute myeloid leukaemia and synergistic with azacitidine. We aimed to evaluate the efficacy and safety of low dose azacitidine plus venetoclax as maintenance therapy in acute myeloid leukaemia.

methodsWe performed a single-centre, single-arm, phase 2 study at the University of Texas MD Anderson Cancer Center in the USA. Eligible patients were adults (aged ≥18 years) with a WHO 2016 diagnosis of acute myeloid leukaemia in complete remission or complete remission with incomplete blood count recovery following intensive or low-intensity induction and not immediately eligible for HSCT. Eastern Cooperative Oncology Group performance status had to be 3 or less. Patients were assigned to maintenance therapy with azacitidine 50 mg/m

findingsBetween Sept 26, 2019, and Oct 26, 2022, 35 patients were enrolled, of whom 25 (71%) were assigned to cohort 1 following intensive induction and ten (29%) to cohort 2 following low-intensity induction. Of 35 patients, 18 (51%) were male and 17 (49%) were female. The median age was 55 years (IQR 41-62). The median number of cycles given was 9 (IQR 2-22) and median follow-up time was 23·3 months (IQR 9·0-30·0). The median relapse-free survival was not reached (95% CI 20·2 to not calculable) in the full cohort, not reached (29·1 to not calculable) in cohort 1, and 30·3 months (16·5 to not calculable) in cohort 2. The 2-year relapse-free survival was 65% (95% CI 50-85) in the full cohort, 71% (53-94) in cohort 1, and 52% (27-100) in cohort 2. The most common grade 3-4 treatment-emergent adverse events were thrombocytopenia (n=6), lung infection (n=4), leukopenia (n=4), and neutropenia (n=3). No deaths occurred during maintenance therapy.

interpretationLow dose azacitidine plus venetoclax is a feasible maintenance strategy in acute myeloid leukaemia following intensive and low-intensity induction.

fundingUniversity of Texas MD Anderson Cancer Center, MDS/AML Moon Shot, Genentech.

Indexed as

Leukemia, Myeloid, AcuteNeoplasm Recurrence, LocalSulfonamidesAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsAzacitidineBridged Bicyclo Compounds, HeterocyclicFemaleHumansMaleMiddle AgedAzacitidineBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclax

Identifiers

PMID38548404
PMCPMC12320475
OpenAlexW4393183571

What OpenQuestion holds

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Registered trials

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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.