Evidence map›Paper›PMID 29352703›Full record

Trial reportThe Lancet. Oncology2018

Inotuzumab ozogamicin in combination with low-intensity chemotherapy for older patients with Philadelphia chromosome-negative acute lymphoblastic leukaemia: a single-arm, phase 2 study.

Hagop Kantarjian, Farhad Ravandi, Nicholas J Short, Xuelin Huang, Nitin Jain, Koji Sasaki, Naval Daver, Naveen Pemmaraju, Joseph D Khoury, Jeffrey Jorgensen and 15 more

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

Trial report in The Lancet. Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 124 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
124citing papers in PubMed, 3 pooled it
27.8field-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.

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

124 citing papers in PubMed, 3 syntheses or guidelines pooled it, 238 citations in OpenAlex.

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  18. Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026
    Review
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64 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 2 institutions in 1 country.

Hagop KantarjianDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: hkantarjian@mdanderson.org.
Farhad RavandiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nicholas J ShortDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Xuelin HuangDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nitin JainDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Koji SasakiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Naval DaverDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Naveen PemmarajuDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Joseph D KhouryDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jeffrey JorgensenDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yesid AlvaradoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Marina KonoplevaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guillermo Garcia-ManeroDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Tapan KadiaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Musa YilmazDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Gautam BortakhurDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jan BurgerDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Steven KornblauDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
William WierdaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Courtney DiNardoDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alessandra FerrajoliDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jovitta JacobDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rebecca GarrisDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Susan O'Brienthe Chao Family Comprehensive Cancer Center, University of California Irvine, Orange County, CA, USA.
Elias JabbourDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · USUniversity of California, Irvine · US

Funding

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

Abstract

backgroundInotuzumab ozogamicin, an anti-CD22 monoclonal antibody bound to a toxin, calicheamicin, has shown single-agent activity in relapsed or refractory acute lymphoblastic leukaemia. We aimed to assess the activity and safety of inotuzumab ozogamicin in combination with low-intensity chemotherapy in older patients with acute lymphoblastic leukaemia.

methodsWe did a single-arm, phase 2 study at the MD Anderson Cancer Center (Houston, TX, USA). Eligible patients were aged 60 years or older and had newly diagnosed, Philadelphia chromosome-negative, acute lymphoblastic leukaemia, and an Eastern Cooperative Oncology Group performance status of 3 or lower. The induction chemotherapy regimen used was mini-hyper-CVD (a lower intensity version of the conventional hyper-CVAD). Odd-numbered cycles (1,3, 5, and 7) comprised intravenous cyclophosphamide (150 mg/m

findingsBetween Nov 12, 2011, and April 22, 2017, 52 patients with a median age of 68 years (IQR 64-72) were enrolled. With a median follow-up of 29 months (IQR 13-48), 2-year progression-free survival was 59% (95% CI 43-72). The most frequent grade 3-4 adverse events were prolonged thrombocytopenia (42 [81%] patients), infections during induction (27 [52%]) and consolidation chemotherapy (36 [69%]), hyperglycaemia (28 [54%]), hypokalaemia (16 [31%]), increased aminotransferases (ten [19%]), hyperbilirubinaemia (nine [17%]), and haemorrhage (seven [15%]). Veno-occlusive disease occurred in four (8%) patients. Six (12%) patients died from adverse events that were deemed treatment related (five [10%] from sepsis and one [2%] from veno-occlusive disease).

interpretationInotuzumab ozogamicin plus mini-hyper-CVD chemotherapy is a safe and active first-line therapy option in older patients with newly diagnosed acute lymphoblastic leukaemia and could represent a new therapy for this population. Randomised, phase 3 trials to evaluate the efficacy of this combination compared with the current standard of care in this setting, combination chemotherapy without inotuzumab ozogamicin, are warranted.

fundingMD Anderson Cancer Center.

Indexed as

Academic Medical CentersAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCancer Care FacilitiesCyclophosphamideDexamethasoneDisease-Free SurvivalDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFemaleGeriatric AssessmentHumansInduction ChemotherapyInotuzumab OzogamicinAntibodies, Monoclonal, HumanizedCyclophosphamideDexamethasoneDoxorubicinInotuzumab OzogamicinVincristine

Identifiers

PMID29352703
PMCPMC11537312
OpenAlexW2783032930

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.