Evidence map›Paper›PMID 15385923›Full record

Trial reportLeukemia2004

Phase III study of all-trans retinoic acid in previously untreated patients 61 years or older with acute myeloid leukemia.

R F Schlenk, S Fröhling, F Hartmann, J Th Fischer, A Glasmacher, F del Valle, W Grimminger, K Götze, C Waterhouse, R Schoch and 16 more

Registry-linked trialAbstract readClinical TrialClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00143975 (Phase II Study on Gemtuzumab Ozogamicin in Combination With All-trans-Retinoic Acid, High-dose Cytarabine and Mitoxantrone in Patients With Primary Refractory Acute Myeloid Leukemia), which is not on this map. Cited by 81 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT00143975 phase2completednot on this map

Phase II Study on Gemtuzumab Ozogamicin in Combination With All-trans-Retinoic Acid, High-dose Cytarabine and Mitoxantrone in Patients With Primary Refractory Acute Myeloid Leukemia

TypeinterventionalSponsorUniversity of UlmRan2004 to 2009Enrolled95ConditionsLeukemia, Myeloid, AcuteArmsCytarabine, Mitoxantrone, Gemtuzumab Ozogamicin, All-trans-Retinoid Acid
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 2 syntheses or guidelines pooled it, 169 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Decitabine plus all-Haematologica · 2026
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  10. Genomic Classification and Prognosis in Acute Myeloid Leukemia.The New England journal of medicine · 2016
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  20. Cancers · 2025
    Review

21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 19 institutions in 2 countries.

R F SchlenkDepartment of Internal Medicine III, University of Ulm, Ulm, Germany. Richard.Schlenk@medizin.uni-ulm.de <Richard.Schlenk@medizin.uni-ulm.de>
S Fröhling
F Hartmann
J Th Fischer
A Glasmacher
F del Valle
W Grimminger
K Götze
C Waterhouse
R Schoch
H Pralle
H G Mergenthaler
M Hensel
E Koller
H Kirchen
J Preiss
H Salwender
H G Biedermann
S Kremers
F Griesinger
A Benner
B Addamo
K Döhner
R Haas
H Döhner
AML Study Group Ulm
Universität Ulm · DEKlinikum Stuttgart · DEAllgemeines Krankenhaus Celle · DECaritas-Krankenhaus St. Josef · DEcts CaritasKlinikum Saarbrücken · DEGerman Cancer Research Center · DEHanusch Hospital · ATHeidelberg University · DEHeinrich Heine University Düsseldorf · DEKiel University · DEKlinikum Oldenburg · DEKrankenhaus der Barmherzigen Brüder Trier · DEKreisklinik Trostberg · DEMünchen Klinik Schwabing · DEStädtisches Klinikum Karlsruhe · DETechnical University of Munich · DEUniversity of Bonn · DEUniversity of Giessen · DEUniversity of Göttingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of our study was (i) to evaluate the impact of all-trans retinoic acid (ATRA) given as adjunct to chemotherapy and (ii) to compare second consolidation vs maintenance therapy in elderly patients with acute myeloid leukemia (AML). A total of 242 patients aged >or=61 years (median, 66.6 years) with AML were randomly assigned to ATRA beginning on day +3 after the initiation of chemotherapy (ATRA-arm, n=122) or no ATRA (standard-arm, n=120) in combination with induction and first consolidation therapy. A total of 61 patients in complete remission (CR) were randomly assigned to second intense consolidation (n=31) or 1-year oral maintenance therapy (n=30). After induction therapy the intention-to-treat analysis revealed a significant difference in CR rates between the ATRA- and the standard-arm (52 vs 39%; P=0.05). Event-free (EFS) and overall survival (OS) were significantly better in the ATRA-compared to the standard-arm (P=0.03 and 0.01, respectively). OS after second randomization was significantly better for patients assigned to intensive consolidation therapy (P<0.001). The multivariate model for survival revealed lactate dehydrogenase, cytogenetic risk group, age, and first and second randomization as prognostic variables. In conclusion, the addition of ATRA to induction and consolidation therapy may improve CR rate, EFS and OS in elderly patients with AML.

Indexed as

Acute DiseaseAgedAged, 80 and overAnemia, Refractory, with Excess of BlastsAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyCytarabineEtoposideHumansIdarubicinLeukemia, MyeloidMiddle AgedPrognosisRemission InductionSurvival RateTransplantation, HomologousCytarabineEtoposideIdarubicinTretinoin

Identifiers

PMID15385923
OpenAlexW2065285477

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.