Evidence map›Paper›PMID 39400388›Full record

Trial reportEuropean journal of haematology2025

Impact of TP53 Mutation Status in Elderly AML Patients When Adding All-Trans Retinoic Acid or Valproic Acid to Decitabine.

Helena Bresser, Claudia Schmoor, Olga Grishina, Dietmar Pfeifer, Johanna Thomas, Usama-Ur Rehman, Martina Crysandt, Edgar Jost, Felicitas Thol, Michael Heuser and 24 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of haematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00867672 (Prospective Randomized Multicenter Phase II Trial of Low-dose Decitabine), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT00867672 phase2completednot on this map

Prospective Randomized Multicenter Phase II Trial of Low-dose Decitabine (DAC) Administered Alone or in Combination With the Histone Deacetylase Inhibitor Valproic Acid (VPA) and All-trans Retinoic Acid (ATRA) in Patients > 60 Years With Acute Myeloid Leukemia Who Are Ineligible for Induction Chemotherapy

TypeinterventionalSponsorUniversity Hospital FreiburgRan2011 to 2016Enrolled204ConditionsAcute Myeloid LeukemiaArmsDecitabine, VPA, ATRA
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
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

34 authors.

Helena BresserDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.ORCID https://orcid.org/0009-0000-3724-5982
Claudia SchmoorClinical Trials Unit, University Medical Center Freiburg, Freiburg, Germany.
Olga GrishinaClinical Trials Unit, University Medical Center Freiburg, Freiburg, Germany.
Dietmar PfeiferDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.
Johanna ThomasDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.
Usama-Ur RehmanDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.
Martina CrysandtDepartment of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, University Hospital Aachen, Aachen, Germany.
Edgar JostDepartment of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, University Hospital Aachen, Aachen, Germany.
Felicitas TholDepartment of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
Michael HeuserDepartment of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
Katharina S GötzeDepartment of Medicine III, Technical University Munich School of Medicine, Klinikum Rechts der Isar, Munich, Germany.
Richard F SchlenkNCT-Trial Center, National Center of Tumor Diseases, Heidelberg, Germany.
Helmut R SalihDepartment of Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.
Marcus M SchittenhelmDepartment of Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.
Gerhard HeilDepartment of Hematology/Oncology, Klinikum Lüdenscheid, Lüdenscheid, Germany.
Carsten SchwaenenDepartment of Medical Oncology, Ortenau Hospital Offenburg, Offenburg, Germany.
Carsten Müller-TidowNCT-Trial Center, National Center of Tumor Diseases, Heidelberg, Germany.
Wolfram BruggerHospital Villingen-Schwenningen, Planegg, Germany.
Andrea KündgenDepartment of Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University, Düsseldorf, Germany.
Maike de WitDepartment of Hematology, Oncology and Palliative Medicine, Vivantes Klinikum Neukoelln, Berlin, Germany.
Aristoteles GiagounidisDepartment of Oncology, Hematology and Palliative Care, Marienhospital Düsseldorf, Düsseldorf, Germany.
Sebastian SchollDepartment of Internal Medicine II, University Hospital Jena, Jena, Germany.
Andreas NeubauerKlinik für Innere Medizin, Schwerpunkt Hämatologie, Onkologie und Immunologie, Philipps University, Marburg, Germany.
Jürgen KrauterDepartment of Internal Medicine III, Braunschweig Municipal Hospital, Braunschweig, Germany.
Gesine BugDepartment of Medicine 2, Goethe University Frankfurt, Frankfurt, Germany.
Annette M MayInstitute of Pathology, University Freiburg, Freiburg, Germany.
Ralph WäschDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.
Justus DuysterDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.
Konstanze DöhnerDepartment of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.
Arnold GanserDepartment of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
Hartmut DöhnerDepartment of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.
Björn HackansonDepartment of Hematology/Oncology, University Medical Center Augsburg, Augsburg, Germany.
Heiko BeckerDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.
Michael LübbertDepartment of Hematology, Oncology and Stem Cell Transplantation, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a randomized phase II trial (AMLSG 14-09, NCT00867672) of elderly, newly diagnosed AML patients, ATRA combined with decitabine (DEC) significantly improved the overall response rate (ORR) and survival also in patients with adverse-risk genetics, without adding toxicity. We performed a post hoc analysis to determine the predictive impact of TP53 status. Despite a nominally higher ORR, the clinically meaningful survival benefit when adding ATRA to DEC was diminished, but not completely negated, in TP53-mutated patients. Indeed, 2 out of 14 TP53-mutated patients (14%) randomized to a DEC + ATRA-containing regimen lived for > 36 months. Further studies of ATRA combined with hypomethylating agents appear warranted in non-M3 AML patients ineligible for HMA/venetoclax therapy. Trial Registration: ClinicalTrials.gov identifier: NCT00867672.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsDecitabineLeukemia, Myeloid, AcuteMutationTretinoinTumor Suppressor Protein p53Valproic AcidAgedAged, 80 and overFemaleHumansMalePrognosisTreatment OutcomeDecitabineTP53 protein, humanTretinoinTumor Suppressor Protein p53Valproic AcidAMLATRAepigeneticsHMATP53

Identifiers

PMID39400388
PMCPMC11707815

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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.