Evidence map›Paper›PMID 24150216›Full record

Trial reportLeukemia2014

Chemomodulation of sequential high-dose cytarabine by fludarabine in relapsed or refractory acute myeloid leukemia: a randomized trial of the AMLCG.

M Fiegl, M Unterhalt, W Kern, J Braess, K Spiekermann, P Staib, A Grüneisen, B Wörmann, D Schöndube, H Serve and 11 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07101588 (Ruxolitinib and Decitabine-Enhanced Conditioning Versus Modified Bu/Cy or BuF Conditioning for the Impact on Relapse of Acute Myeloid Leukemia in First Complete Remission), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

NCT07101588 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Ruxolitinib and Decitabine-Enhanced Conditioning Versus Modified Bu/Cy or BuF Conditioning for the Impact on Relapse of Acute Myeloid Leukemia in First Complete Remission (CR1)After Allogeneic Hematopoietic Stem Cell Transplantation: A Multicenter, Prospective Randomized Controlled Trial

TypeinterventionalSponsorChinese PLA General HospitalRan2025 to 2028Enrolled200ConditionsAllogeneic Hematopoietic Stem Cell Transplantation (HSCT)ArmsRuxolitinib, Decitabine
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Cytotoxic therapy in acute myeloid leukemia: not quite dead yet.Hematology. American Society of Hematology. Education Program · 2018
    Review
  8. 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

21 authors at 10 institutions in 1 country.

M FieglDepartment of Internal Medicine III, University Hospital of Munich, Munich, Germany.
M UnterhaltDepartment of Internal Medicine III, University Hospital of Munich, Munich, Germany.
W KernMLL Munich Leukemia Laboratory, Munich, Germany.
J BraessDepartment of Hematology and Oncology, Klinikum Barmherzige Brüder, Regensburg, Germany.
K SpiekermannDepartment of Internal Medicine III, University Hospital of Munich, Munich, Germany.
P StaibDepartment of Hematology and Oncology, St-Antonius-Hospital, Eschweiler, Germany.
A GrüneisenDepartment of Hematology and Oncology, Vivantes Klinikum Berlin-Neukölln, Berlin, Germany.
B WörmannGerman Society for Hematology and Oncology, Berlin, Germany.
D SchöndubeDepartment of Hematology and Oncology, Helios Klinikum Berlin Buch, Berlin, Germany.
H ServeDepartment of Hematology and Oncology, J.W. Goethe-University, Frankfurt, Germany.
A ReichleDepartment of Internal Medicine II, University Hospital of Regensburg, Regensburg, Germany.
M HentrichDepartment of Hematology and Oncology, Krankenhaus Harlaching, Munich, Germany.
X SchielDepartment of Hematology and Oncology, Krankenhaus Harlaching, Munich, Germany.
C SauerlandInstitute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
A HeineckeInstitute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
C RiegerDepartment of Internal Medicine III, University Hospital of Munich, Munich, Germany.
D BeelenDepartment of Hematopoietic Stem Cell Transplantation, University of Essen, Essen, Germany.
W E BerdelDepartment of Medicine A, Hematology and Oncology, University of Muenster, Muenster, Germany.
T BüchnerDepartment of Medicine A, Hematology and Oncology, University of Muenster, Muenster, Germany.
W HiddemannDepartment of Internal Medicine III, University Hospital of Munich, Munich, Germany.
German AML Cooperative Group (AMLCG)
LMU Klinikum · DEMünchen Klinik Harlaching · DEUniversity of Münster · DEHelios Hospital Berlin-Buch · DEKrankenhaus Barmherzige Brüder · DEMunich Leukemia Laboratory (Germany) · DESankt-Antonius-Hospital Eschweiler · DEUniversity Hospital Regensburg · DEUniversity of Duisburg-Essen · DEVivantes Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chemomodulation of cytarabine by fludarabine has been attributed with a higher antileukemic efficacy, but randomized trials to address this question are rare. We therefore conducted a multicenter, randomized phase III study to evaluate the antileukemic efficacy of adding fludarabine to sequential high-dose cytarabine+idarubicin (SHAI) re-induction chemotherapy in relapsed or refractory acute myeloid leukemia (AML). Patients (n=326, of which 281 were evaluable) were randomly assigned to SHAI (cytarabine, 1 g/m(2) bid, days 1-2 and 8-9 (3 g/m(2) for patients ≤ 60 years with refractory AML or ≥ 2nd relapse); idarubicin 10 mg/m(2) daily, days 3-4 and 10-11) or F-SHAI (SHAI with fludarabine, 15 mg/m(2), 4 h before cytarabine). Although complete remission (CR) rates (35% SHAI and 44% F-SHAI) and overall survival did not differ between both regimens, fludarabine prolonged time to treatment failure from 2.04 to 3.38 months (median, P<0.05). Twenty-seven percent of patients proceeded to allogeneic stem cell transplantation, with a significantly higher number of patients in CR or incomplete remission in the F-SHAI group (22 vs 10%, P<0.01). In conclusion, fludarabine has a beneficial, although moderate, impact on the antileukemic efficacy of high-dose cytarabine-based salvage therapy for relapsed and refractory AML.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCytarabineFemaleHumansLeukemia, Myeloid, AcuteMaleMiddle AgedPrognosisRecurrenceSurvival AnalysisVidarabineYoung AdultCytarabinefludarabineVidarabine

Identifiers

PMID24150216
OpenAlexW2015131391

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.