Evidence map›Paper›PMID 18565853›Full record

Trial reportBlood2008

A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome.

Stefan Faderl, Farhad Ravandi, Xuelin Huang, Guillermo Garcia-Manero, Alessandra Ferrajoli, Zeev Estrov, Gautam Borthakur, Srdan Verstovsek, Deborah A Thomas, Monica Kwari and 1 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00088218 (Randomized Phase II Study of Clofarabine Alone Versus Clofarabine in Combination With Low-Dose Cytarabine in Previously Untreated Patients >= 60 Years With AML and High-Risk MDS), which is not on this map. Cited by 73 papers.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed
13.5field-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.

NCT00088218 phase2completednot on this map

Randomized Phase II Study of Clofarabine Alone Versus Clofarabine in Combination With Low-Dose Cytarabine in Previously Untreated Patients >= 60 Years With AML and High-Risk MDS

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2004 to 2008Enrolled95ConditionsAcute Myeloid Leukemia, Myelodysplastic SyndromeArmsClofarabine, Ara-C
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 200 citations in OpenAlex.

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  14. Phase I-II study of clofarabine-melphalan-alemtuzumab conditioning for allogeneic hematopoietic cell transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2012
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  17. Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine.Proceedings of the National Academy of Sciences of the United States of America · 2010
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13 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

11 authors at 1 institution in 1 country.

Stefan FaderlDepartment of Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. sfaderl@mdanderson.org
Farhad Ravandi
Xuelin Huang
Guillermo Garcia-Manero
Alessandra Ferrajoli
Zeev Estrov
Gautam Borthakur
Srdan Verstovsek
Deborah A Thomas
Monica Kwari
Hagop M Kantarjian
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients. We have conducted an adaptively randomized study of lower-dose clofarabine with or without low-dose cytarabine in previously untreated patients with AML aged 60 years and older. Patients received 30 mg/m(2) clofarabine intravenously daily for 5 days with or without 20 mg/m(2) cytarabine subcutaneously daily for 14 days as induction. Consolidation consisted of 3 days of clofarabine with or without 7 days of cytarabine. Seventy patients were enrolled. The median age was 71 years (range, 60-83 years). Sixteen patients received clofarabine and 54 the combination. Overall, 56% achieved complete remission (CR). CR rate was significantly higher with the combination (63% vs 31%; P = .025). Induction mortality was 19% with the combination versus 31% with clofarabine alone (P = .276). The combination showed better event-free survival (7.1 months vs 1.7 months; P = .04), but not overall survival (11.4 months vs 5.8 months; P = .1). Clofarabine plus low-dose cytarabine has a higher response rate than clofarabine alone with comparable toxicity. This trial is registered at www.clinicaltrials.gov as no. NCT00088218.

Indexed as

Adenine NucleotidesAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsArabinonucleosidesChromosome AberrationsClofarabineCytarabineDisease-Free SurvivalDrug Administration ScheduleFemalefms-Like Tyrosine Kinase 3HumansLeukemia, Myeloid, AcuteMaleAdenine NucleotidesAntineoplastic AgentsArabinonucleosidesClofarabineCytarabineFLT3 protein, humanfms-Like Tyrosine Kinase 3

Identifiers

PMID18565853
PMCPMC4081352
OpenAlexW1965658643

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.