Evidence map›Paper›PMID 30115541›Full record

Trial reportThe Lancet. Haematology2018

Cladribine and low-dose cytarabine alternating with decitabine as front-line therapy for elderly patients with acute myeloid leukaemia: a phase 2 single-arm trial.

Tapan M Kadia, Jorge Cortes, Farhad Ravandi, Elias Jabbour, Marina Konopleva, Christopher B Benton, Jan Burger, Koji Sasaki, Gautam Borthakur, Courtney D DiNardo and 14 more

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

Trial report in The Lancet. Haematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed
7.3field-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

58 citing papers in PubMed, 90 citations in OpenAlex.

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  11. Getting the right combination to break the epigenetic code.Nature reviews. Clinical oncology · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 2 institutions in 1 country.

Tapan M KadiaDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: tkadia@mdanderson.org.
Jorge CortesDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Farhad RavandiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Elias JabbourDepartment 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.
Christopher B BentonDepartment 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.
Koji SasakiDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Gautam BorthakurDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Courtney D DiNardoDepartment 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.
Naval DaverDepartment 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.
Xuemei WangDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Keyur PatelDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jeffrey L JorgensenDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sa WangDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Susan O'BrienDivision of Hematology/Oncology, Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA, USA.
Sherry PierceDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Carla TuttleDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Zeev EstrovDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Srdan VerstovsekDepartment 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.
Hagop KantarjianDepartment 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
TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHPALL, ELIZABETH J · 1990 to 2014
$41.8M
NCI NIH HHS P01 CA049639NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundFront-line therapy for elderly or unfit patients with acute myeloid leukaemia (AML) remains unsatisfactory with poor outcomes and excessive toxicity. We studied a new low-intensity regimen of cladribine combined with low-dose cytarabine alternating with decitabine, aimed at improving outcomes in this population. Based on our previous experience, we hypothesised that this combination would be safe and more effective than current approaches with hypomethylating agents.

methodsIn this single-arm, open-label, single-centre phase 2 study, we enrolled patients aged 60 years or older with previously untreated AML or high-risk myelodysplastic syndrome who had adequate organ function and an Eastern Cooperative Oncology Group performance status of 2 or less. Patients were treated with cladribine plus low-dose cytarabine for two 28-day cycles alternating with decitabine for two 28-day cycles, for up to 18 cycles. Induction therapy (cycle 1) consisted of cladribine 5 mg/m

findingsBetween Feb 17, 2012, and July 6, 2017, 118 patients were enrolled and treated, among whom 48 (41%) had an adverse karyotype, 20 (17%) had therapy-related AML, 18 (15%) had treated secondary AML, and 20 (17%) had TP53 mutations. Median disease-free survival was 10·8 months (IQR 5·4-25·9). 80 (68%) patients achieved objective response: 69 (58%) achieved a complete response and 11 (9%) patients had complete response with incomplete count recovery. The median overall survival was 13·8 months (6·9-28·6). The regimen was well tolerated, with one (1%) death within the first 4 weeks and eight (7%) deaths within the first 8 weeks. The most common non-haematological adverse events of grade 3 or worse were infection (88 [75%] patients), elevated total bilirubin (26 [22%] patients), rash (13 [11%] patients), and nausea (13 [11%] patients).

interpretationThe combination of cladribine and low-dose cytarabine alternating with decitabine appears to be a safe and highly effective regimen for the treatment of elderly or unfit patients with newly diagnosed AML. Further testing of this regimen is warranted, and could help to provide a new, effective option for reduced-intensity therapy in this population.

fundingPart supported by the National Institutes of Health.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAzacitidineCladribineCytarabineDecitabineDisease-Free SurvivalDose-Response Relationship, DrugFemaleHumansLeukemia, Myeloid, AcuteMaleMiddle AgedSurvival AnalysisAzacitidineCladribineCytarabineDecitabine

Identifiers

PMID30115541
PMCPMC6775639
OpenAlexW2886917823

What OpenQuestion holds

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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.