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Acute Myeloid LeukemiaPhase 2/3NCT00151242

Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 2/3 study testing Cytarabine, Idarubicin and Etoposide in people with Acute Myeloid Leukemia, run by University of Ulm at 34 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Cytarabine, Idarubicin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
920 participants
Where
34 sitesin 2 countries
Study dates
Jul 2004to Aug 2013
Phase
Phase 2/3
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia [APL])
  • Ages 18-60 years
  • Written informed consent of each patient at study entry.
  • Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories

Who cannot join

  • Bleeding independent of the AML
  • Acute promyelocytic leukemia
  • Uncontrollable infection
  • Participation in a concurrent clinical study
  • Insufficiency of the kidneys (creatinine > 1.5x upper normal serum level), of the liver (bilirubin, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV
  • Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
Show all 9Show fewer
  • No consent for registration, storage and processing of the individual disease-characteristics and course.
  • Performance status WHO > 2
  • Pregnancy

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

Germany30 sites

  • Department of General Internal Medicine, University Hospital of Bonn

    Bonn, 53127

  • Medical Department I, Hospital Bremen-Mitte

    Bremen, 28177

  • Clinical Center of Hematology and Oncology, University Hospital of Düsseldorf

    Düsseldorf, 40225

  • Department of Hematology and Oncology, Hospital Essen Süd, Ev. Hospital of Essen-Werden

    Essen, 45239

  • Medical Department III, Hematology/Oncology, University of Frankfurt

    Frankfurt, 60590

  • Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst

    Frankfurt, 65929

  • Internal Medicine I, University of Freiburg

    Freiburg im Breisgau, 79106

  • Medical Department IV, University Hospital of Giessen

    Giessen, 35392

  • Department of Internal Medicine, Wilhelm-Anton-Hospital gGmbH

    Goch, 47574

  • Centre of Internal Medicine, University Hospital Göttingen

    Göttingen, 37075

  • Department of Oncology and Hematology, University Hospital Eppendorf

    Hamburg, 20246

  • Medical Department II, Hematology and Oncology, General Hospital Altona

    Hamburg, 22763

  • Medical Department III, Clinical Center Hanau

    Hanau, 63450

  • Medical Department III, Hospital Hannover-Siloah

    Hanover, 30449

  • Department of Hematology, Hematology and Oncology, Medizinische Hochschule Hannover

    Hanover, 30625

  • Department of Internal 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 Internal Medicine/Hematology and Oncology, Cartias Hospital Lebach

    Lebach, 66822

  • Department of Hematology and Oncology, Hospital of Lüdenscheid

    Lüdenscheid, 58505

  • Department of Hematology and Internal Oncology, University Hospital of Mainz

    Mainz, 55101

  • Medical Department III, Clinical Center Rechts der Isar

    München, 81675

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

    Oldenburg, 26133

  • Department of Hematology and Oncology, Caritas Hospital St. Theresia

    Saarbrücken, 66113

  • Department of Oncology, Clinical Center of Stuttgart

    Stuttgart, 70174

  • Medical Department II, Diakonie Hospital

    Stuttgart, 70176

  • Medical Department I, Hospital of Barmherzige Brüder

    Trier, 54292

  • Department of Internal Medicine II, University Hospital of Tübingen

    Tübingen, 72076

  • Medical Clinic II-Hematology/Oncology, Hospital Villingen-Schwenningen

    Villingen-Schwenningen, 78050

  • Medical Department I, Helios Hospital Wuppertal

    Wuppertal, 42283

Other trials in Germany

Austria4 sites

  • Department of Hematology/Oncology, University Hospital Innsbruck

    Innsbruck, 6020

  • Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern

    Linz, 4010

  • Medical Department III, St. Johann-Hospital

    Salzburg, 5020

  • Center of Hematology and Oncology, Hanusch-Hospital

    Vienna, 1140

Other trials in Austria

About this study

Official title: Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).

Read the detailed description

First Induction Therapy:

  • Cytarabine 100 mg/m² cont. i.v. days 1-7
  • Idarubicin 12 mg/m² i.v. days 1,3,5
  • Etoposide 100 mg/m² i.v. days 1-3
  • ± ATRA 45 mg/m² p.o. days 6-8
  • ATRA 15 mg/m² p.o. days 9-21

Second Induction Therapy:

  • Cytarabine 100 mg/m² cont. i.v. days 1-7
  • Idarubicin 12 mg/m² i.v. days 1 and 3
  • Etoposide 100 mg/m² i.v. days 1-3
  • ± ATRA 45 mg/m² p.o. days 6-8
  • ATRA 15 mg/m² p.o. days 9-21

Consolidation Therapy:

cohort 1 (<= ID 336)

  • Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5
  • ± ATRA 15 mg/m² p.o. Tag 6-21
  • Pegfilgrastim 6 mg s.c day 10 cohort 2 (> ID 336)
  • Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3
  • ± ATRA 15 mg/m² p.o. Tag 4-21
  • Pegfilgrastim 6 mg s.c day 8
Being tested
Cytarabine, Idarubicin, Etoposide, All-trans retinoic acid, Pegfilgrastim
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.

  • CytarabineDrug

    100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3

  • IdarubicinDrug

    12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)

  • EtoposideDrug

    100mg/m² i.v. day 1-3 (induction therapy)

  • All-trans retinoic acidDrug

    45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)

  • PegfilgrastimDrug

    Also called Neulasta

    6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)

Study groups in NCT00151242
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Etoposide; Drug: Pegfilgrastim
2ExperimentalNot described
Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Etoposide; Drug: All-trans retinoic acid; Drug: Pegfilgrastim

What is being measured

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

  1. Complete remission (CR)-rate after induction therapy

    Measured: after the second induction cycle

  2. Relapse-free survival, one year after consolidation therapy with high-dose cytarabine considering different temporal sequences (1-3-5 versus 1-2-3) of the consolidation therapy

    Measured: One year after consolidation therapy

  3. Event-free survival

    Measured: two years

Secondary outcomes (8)

  1. Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs

    Measured: during therapy

  2. Cumulative incidence of relapse

    Measured: two years

  3. Cumulative incidence of death

    Measured: two years

  4. Overall survival

    Measured: two years

  5. Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle

    Measured: during consolidation therapy

  6. Timely sequence of the pegfilgrastim-concentration in correlation to the absolute neutrophil counts after each consolidation cycle

    Measured: during consolidation therapy

  7. Hematologic and non-hematologic toxicity after consolidation therapy with high-dose cytarabine considering the different consolidation schemes (day 1-3-5 versus day 1-2-3)

    Measured: during consolidation therapy

  8. Days in hospital after each consolidation cycle

    Measured: after consolidation therapy

Timeline

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

  1. First posted8 Sep 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionAug 2011
  4. Study completionAug 2013

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00151242
Sponsor's protocol ID
AMLSG07-04
Status last verified
Sep 2017
First submitted
6 Sep 2005
Last updated
20 Sep 2017
Results posted
No

Publications

  • Schlenk RF, Lubbert M, Benner A, Lamparter A, Krauter J, Herr W, Martin H, Salih HR, Kundgen A, Horst HA, Brossart P, Gotze K, Nachbaur D, Wattad M, Kohne CH, Fiedler W, Bentz M, Wulf G, Held G, Hertenstein B, Salwender H, Gaidzik VI, Schlegelberger B, Weber D, Dohner K, Ganser A, Dohner H; German-Austrian Acute Myeloid Leukemia Study Group. All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study. Ann Hematol. 2016 Dec;95(12):1931-1942. doi: 10.1007/s00277-016-2810-z. Epub 2016 Oct 3.

    PubMed 27696203

  • Schlenk RF, Kayser S, Bullinger L, Kobbe G, Casper J, Ringhoffer M, Held G, Brossart P, Lubbert M, Salih HR, Kindler T, Horst HA, Wulf G, Nachbaur D, Gotze K, Lamparter A, Paschka P, Gaidzik VI, Teleanu V, Spath D, Benner A, Krauter J, Ganser A, Dohner H, Dohner K; German-Austrian AML Study Group. Differential impact of allelic ratio and insertion site in FLT3-ITD-positive AML with respect to allogeneic transplantation. Blood. 2014 Nov 27;124(23):3441-9. doi: 10.1182/blood-2014-05-578070. Epub 2014 Sep 30.

    PubMed 25270908

  • 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

  • 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

  • Schlenk RF, Dohner K, Kneba M, Gotze K, Hartmann F, Del Valle F, Kirchen H, Koller E, Fischer JT, Bullinger L, Habdank M, Spath D, Groner S, Krebs B, Kayser S, Corbacioglu A, Anhalt A, Benner A, Frohling S, Dohner H; German-Austrian AML Study Group (AMLSG). Gene mutations and response to treatment with all-trans retinoic acid in elderly patients with acute myeloid leukemia. Results from the AMLSG Trial AML HD98B. Haematologica. 2009 Jan;94(1):54-60. doi: 10.3324/haematol.13378. Epub 2008 Dec 4.

    PubMed 19059939

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cytarabine, Idarubicin and Etoposide in people with Acute Myeloid Leukemia, run by University of Ulm at 34 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 9 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 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Complete remission (CR)-rate after induction therapy (time frame: after the second induction cycle). The study lists 3 primary outcomes in all. 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 NCT00151242, which also lists 5 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 20 Sep 2017.

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