Evidence map›Paper›PMID 25519749›Full record

Trial reportBlood2015

TIDEL-II: first-line use of imatinib in CML with early switch to nilotinib for failure to achieve time-dependent molecular targets.

David T Yeung, Michael P Osborn, Deborah L White, Susan Branford, Jodi Braley, Alan Herschtal, Michael Kornhauser, Samar Issa, Devendra K Hiwase, Mark Hertzberg and 14 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
8.5field-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

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 102 citations in OpenAlex.

  1. Pooled it
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  14. Assessment of TNF α and IL-6 Levels in Indian Patients of CML and their Correlation with Early Molecular Response: An Observational Study.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2025
    Article
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  18. Accelerated-phase CML: de novo and transformed.Hematology. American Society of Hematology. Education Program · 2023
    Article
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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

24 authors at 8 institutions in 2 countries.

David T YeungDepartment of Haematology, and Department of Genetics and Molecular Pathology and Centre for Cancer Biology, SA Pathology, Adelaide, Australia; Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia; Australasian Leukemia and Lymphoma Group, Melbourne, Australia;
Michael P OsbornDepartment of Haematology, and Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia; Australasian Leukemia and Lymphoma Group, Melbourne, Australia;
Deborah L WhiteDiscipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia; Australasian Leukemia and Lymphoma Group, Melbourne, Australia; Cancer Theme, South Australia Health and Medical Research Institute, Adelaide, Australia;
Susan BranfordDepartment of Genetics and Molecular Pathology and Centre for Cancer Biology, SA Pathology, Adelaide, Australia; Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia; School of Molecular and Biomedical Science, and School of Pharmacy and Medical Science, University of South Australia, Adelaide, Australia;
Jodi BraleyDepartment of Genetics and Molecular Pathology and Centre for Cancer Biology, SA Pathology, Adelaide, Australia;
Alan HerschtalCentre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia;
Michael KornhauserCentre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia;
Samar IssaAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Middlemore Hospital, Auckland, New Zealand;
Devendra K HiwaseDepartment of Haematology, and Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia; Australasian Leukemia and Lymphoma Group, Melbourne, Australia;
Mark HertzbergAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Prince of Wales Hospital, Sydney, Australia; School of Medicine, University of Sydney, Sydney, Australia;
Anthony P SchwarerAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Box Hill Hospital, Melbourne, Australia;
Robin FilshieAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; St. Vincent's Hospital Melbourne, Melbourne, Australia;
Christopher K ArthurAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Royal North Shore Hospital, Sydney, Australia;
Yiu Lam KwanAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Concord Hospital, Sydney, Australia;
Judith TrotmanAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; School of Medicine, University of Sydney, Sydney, Australia; Concord Hospital, Sydney, Australia;
Cecily J ForsythAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Gosford Hospital, Gosford, Australia;
John TaperAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; School of Medicine, University of Sydney, Sydney, Australia; Nepean Hospital, Penrith, Australia;
David M RossDepartment of Haematology, and Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia; Australasian Leukemia and Lymphoma Group, Melbourne, Australia;
Jennifer BeresfordCentre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia;
Constantine TamAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Peter MacCallum Cancer Centre, Melbourne, Australia;
Anthony K MillsAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Princess Alexandra Hospital, Brisbane, Australia; and.
Andrew P GriggAustralasian Leukemia and Lymphoma Group, Melbourne, Australia; Department of Clinical Haematology, Austin Hospital and University of Melbourne, Melbourne, Australia.
Timothy P HughesDepartment of Haematology, and Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia; Australasian Leukemia and Lymphoma Group, Melbourne, Australia; Cancer Theme, South Australia Health and Medical Research Institute, Adelaide, Australia;
Australasian Leukaemia and Lymphoma Group
Australasian Leukaemia and Lymphoma Group · AUPeter MacCallum Cancer Centre · AUThe University of Adelaide · AUBox Hill Hospital · AUCentre for Cancer Biology · AUConcord Repatriation General Hospital · AUGosford Hospital · AUPrince of Wales Hospital · AU

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

The Therapeutic Intensification in De Novo Leukaemia (TIDEL)-II study enrolled 210 patients with chronic phase chronic myeloid leukemia (CML) in two equal, sequential cohorts. All started treatment with imatinib 600 mg/day. Imatinib plasma trough level was performed at day 22 and if <1000 ng/mL, imatinib 800 mg/day was given. Patients were then assessed against molecular targets: BCR-ABL1 ≤10%, ≤1%, and ≤0.1% at 3, 6, and 12 months, respectively. Cohort 1 patients failing any target escalated to imatinib 800 mg/day, and subsequently switched to nilotinib 400 mg twice daily for failing the same target 3 months later. Cohort 2 patients failing any target switched to nilotinib directly, as did patients with intolerance or loss of response in either cohort. At 2 years, 55% of patients remained on imatinib, and 30% on nilotinib. Only 12% were >10% BCR-ABL1 at 3 months. Confirmed major molecular response was achieved in 64% at 12 months and 73% at 24 months. MR4.5 (BCR-ABL1 ≤0.0032%) at 24 months was 34%. Overall survival was 96% and transformation-free survival was 95% at 3 years. This trial supports the feasibility and efficacy of an imatinib-based approach with selective, early switching to nilotinib. This trial was registered at www.anzctr.org.au as #12607000325404.

Indexed as

AdolescentAdultAgedAged, 80 and overBenzamidesFemaleFusion Proteins, bcr-ablHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedPiperazinesProtein Kinase InhibitorsPyrimidinesSurvival AnalysisBenzamidesFusion Proteins, bcr-ablImatinib MesylatenilotinibPiperazinesProtein Kinase InhibitorsPyrimidines

Identifiers

PMID25519749
PMCPMC5161008
OpenAlexW2106392592

What OpenQuestion holds

Textmetadata
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.