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Acute Myeloid LeukemiaPhase 3NCT00146120

Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

A Phase 3 study testing Idarubicin, Cytosin-Arabinosid and Etoposide in people with Acute Myeloid Leukemia, run by University of Ulm at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The concept of the investigators risk-adapted multicenter treatment trial for younger adults, AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after first induction therapy and/or high… Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Idarubicin, Cytosin-Arabinosid and Etoposide
How many people
400 participants
Where
22 sitesin 2 countries
Study dates
May 1998to May 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
  • Cytogenetical tests must be performed for each patient
  • Age: 16 - 60 years
  • All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.

Who cannot join

  • Organic insufficiency: Insufficiency of the kidneys (Crea > 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP > 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction < 0.5
  • Secondary malignom
  • Other severe diseases
  • Pregnancy
  • Participation in an concurrent clinical study

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

Germany20 sites

  • Department of General Internal Medicine, University Hospital of Bonn

    Bonn, 53127

  • Department of Internal Medicine Hematology, Heinrich-Heine University

    Düsseldorf, 40225

  • Department of Interial Medicine III, City Hospital Frankfurt Am Main - Höchst

    Frankfurt, 65927

  • Medical Department IV, University of Gießen

    Giessen, 35392

  • Department of Interial Medicine, Wilhelm-Anton-Hospital Goch

    Goch, 47574

  • Centre of Interial Medicine, University of Göttingen

    Göttingen, 37075

  • Medical Department III of Hematology and Oncology, General Hospital Altona

    Hamburg, 22763

  • Department of Interial Medicine V, University of Heidelberg

    Heidelberg, 69120

  • Department of Interial Medicine I, University Hospital of Saarland

    Homburg, 66421

  • Medical Department II, City Hospital Karlsruhe gGmbH

    Karlsruhe, 76133

  • Medical Department II, University Hospital of Kiel

    Kiel, 24116

  • Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach

    Lebach, 66822

  • I. Medical Department, City Hospital München-Schwabing

    München, 80804

  • Medical Department III, Clinical Center rechts der Isar

    München, 81675

  • Department of Hematology and Oncology, City Hospital Neunkirchen gGmbH

    Neunkirchen, 66538

  • Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH

    Oldenburg, 26133

  • Department of Hematologie and Oncology, Caritas Hospital St. Theresa Saarbrücken

    Saarbrücken, 66113

  • Clinikal Cetner of Stuttgart, Center of Oncology

    Stuttgart, 70174

  • Medical Department I, Clinical Center of Stuttgart

    Stuttgart, 70191

  • Hospital of Barmherzige Brüder, I Medical Department

    Trier, 54292

Other trials in Germany

Austria2 sites

  • Department of Hematology / Oncology, University Hospital of Innsbruck

    Innsbruck, 6020

  • III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien

    Vienna, 1140

Other trials in Austria

About this study

The concept of the investigators risk-adapted multicenter treatment trial for younger adults, AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after first induction therapy and/or high risk karyotype [abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p), complex]; intermediate-risk: complete remission after induction therapy and intermediate risk karyotype [normal, abn(11q23), abn(16q22), other rare aberrations]; low-risk: complete remission after induction therapy and low risk karyotype [t(8;21)]. Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment consists of a first induction therapy with ICE followed by a second cycle ICE in case of response to first induction therapy. Patients with refractory disease after first induction therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is extended from the family to unrelated persons. All patients achieving a CR after induction therapy with ICE are assigned to a first consolidation therapy with HAM. For intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended during the hematological recovery after the first consolidation. Second consolidation therapy was stratified according to the risk definition. For high risk patients a allogeneic transplantation is assigned from a related or unrelated donor preferentially after a dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a family donor and normal karyotype at diagnosis are randomized between an autologous stem cell transplantation and a second course of HAM. The other intermediate-risk patients are assigned to autologous transplantation. For low-risk patients a second course of HAM is assigned.

Being tested
Idarubicin, Cytosin-Arabinosid, Etoposide, All-trans Retinoid acid
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. relapse-free survival

    Measured: two years

Secondary outcomes (1)

  1. overall survival

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study startMay 1998
  3. Primary completionMay 2005
  4. Study completionMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146120
Sponsor's protocol ID
AMLHD98A
Status last verified
Dec 2008
First submitted
1 Sep 2005
Last updated
9 Feb 2009
Results posted
No

Publications

  • Prochazka KT, Pregartner G, Rucker FG, Heitzer E, Pabst G, Wolfler A, Zebisch A, Berghold A, Dohner K, Sill H. Clinical implications of subclonal TP53 mutations in acute myeloid leukemia. Haematologica. 2019 Mar;104(3):516-523. doi: 10.3324/haematol.2018.205013. Epub 2018 Oct 11.

    PubMed 30309854

  • Papaemmanuil E, Gerstung M, Bullinger L, Gaidzik VI, Paschka P, Roberts ND, Potter NE, Heuser M, Thol F, Bolli N, Gundem G, Van Loo P, Martincorena I, Ganly P, Mudie L, McLaren S, O'Meara S, Raine K, Jones DR, Teague JW, Butler AP, Greaves MF, Ganser A, Dohner K, Schlenk RF, Dohner H, Campbell PJ. Genomic Classification and Prognosis in Acute Myeloid Leukemia. N Engl J Med. 2016 Jun 9;374(23):2209-2221. doi: 10.1056/NEJMoa1516192.

    PubMed 27276561

  • Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.

    PubMed 22965967

  • Gaidzik VI, Bullinger L, Schlenk RF, Zimmermann AS, Rock J, Paschka P, Corbacioglu A, Krauter J, Schlegelberger B, Ganser A, Spath D, Kundgen A, Schmidt-Wolf IG, Gotze K, Nachbaur D, Pfreundschuh M, Horst HA, Dohner H, Dohner K. RUNX1 mutations in acute myeloid leukemia: results from a comprehensive genetic and clinical analysis from the AML study group. J Clin Oncol. 2011 Apr 1;29(10):1364-72. doi: 10.1200/JCO.2010.30.7926. Epub 2011 Feb 22.

    PubMed 21343560

  • Schlenk RF, Dohner K, Mack S, Stoppel M, Kiraly F, Gotze K, Hartmann F, Horst HA, Koller E, Petzer A, Grimminger W, Kobbe G, Glasmacher A, Salwender H, Kirchen H, Haase D, Kremers S, Matzdorff A, Benner A, Dohner H. Prospective evaluation of allogeneic hematopoietic stem-cell transplantation from matched related and matched unrelated donors in younger adults with high-risk acute myeloid leukemia: German-Austrian trial AMLHD98A. J Clin Oncol. 2010 Oct 20;28(30):4642-8. doi: 10.1200/JCO.2010.28.6856. Epub 2010 Aug 30.

    PubMed 20805454

  • Kayser S, Schlenk RF, Londono MC, Breitenbuecher F, Wittke K, Du J, Groner S, Spath D, Krauter J, Ganser A, Dohner H, Fischer T, Dohner K; German-Austrian AML Study Group (AMLSG). Insertion of FLT3 internal tandem duplication in the tyrosine kinase domain-1 is associated with resistance to chemotherapy and inferior outcome. Blood. 2009 Sep 17;114(12):2386-92. doi: 10.1182/blood-2009-03-209999. Epub 2009 Jul 14.

    PubMed 19602710

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idarubicin, Cytosin-Arabinosid and Etoposide in people with Acute Myeloid Leukemia, run by University of Ulm at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

relapse-free survival (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146120, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.

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