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Acute Myeloid LeukemiaPhase 3NCT00893399

Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation

A Phase 3 study testing Gemtuzumab Ozogamicin (Mylotarg) and standard chemotherapy in people with Acute Myeloid Leukemia, run by University of Ulm at 60 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

Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation. Before Amendment No. 4 (December 2013): Primary Efficacy Objective: Evaluation of efficacy based on event-free survival (EFS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Gemtuzumab Ozogamicin (Mylotarg) and standard chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
60 sitesin 2 countries
Study dates
12 May 2010to 1 Sep 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification.
  • Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
  • Age ≥ 18 years. There is no upper age limit.
  • No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 5 days during the diagnostic screening phase.
  • Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration.
  • Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and within one year after the last dose of chemotherapy.
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  • Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control: one highly effective method (e.g., IUD, hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap).
  • "Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
  • Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy.
  • Signed written informed consent.

Who cannot join

  • AML with other recurrent genetic changes (according to WHO 2008):
  • AML with t(8;21)(q22;q22); RUNX1-RUNX1T1
  • AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
  • AML with t(15;17)(q22;q12); PML-RARA (or other translocations involving RARA)
  • AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL)
  • AML with t(6;9)(p23;q34); DEK-NUP214
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  • AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1.
  • Performance status WHO > 2.
  • Patients with ejection fraction < 50% by MUGA or ECHO scan within 14 days of day 1.
  • Organ insufficiency:
  • creatinine > 1.5x upper normal serum level
  • bilirubin, AST or ALP > 2.5x upper normal serum level, not attributable to AML
  • heart failure NYHA III/IV
  • severe obstructive or restrictive ventilation disorder.
  • Uncontrolled infection.
  • Severe neurological or psychiatric disorder interfering with ability of giving an informed consent.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
  • Known positive for HIV, active HBV, HCV, or Hepatitis A infection.
  • Bleeding disorder independent of leukemia.
  • No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.

Trial locations and contacts

60 sites in 2 countries.

60 sites in 2 countries

Germany53 sites

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, 63739

  • Ubbo-Emmius-Klinik Aurich

    Aurich, 26603

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

  • Vivantes Klinikum am Urban

    Berlin, 10967

  • Vivantes Klinikum Neukölln

    Berlin, 12351

  • Charité Berlin - Campus Virchow Klinikum

    Berlin, 13353

  • Knappschaftskrankenhaus Bochum-Langendreer

    Bochum, 44892

  • Universitätsklinikum Bonn

    Bonn, 53111

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Klinikum Bremen-Mitte

    Bremen, 28177

  • Klinikum Darmstadt

    Darmstadt, 64283

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Kliniken Essen Süd, Ev. Krankenhaus Essen-Werden gGmbH

    Essen, 45239

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • St. Franziskus Hospital

    Flensburg, 24939

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt-Höchst, 65929

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Medizinisches Versorgungszentrum Osthessen GmbH

    Fulda, 36043

  • Universitätsklinikum Gießen

    Giessen, 35392

  • Wilhelm-Anton-Hospital gGmbH Goch

    Goch, 47574

  • Universitätsklinikum Göttingen

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Evangelisches Krankenhaus Hamm gGmbH

    Hamm, 59063

  • Klinikum Hanau

    Hanau, 63450

  • KRH Klinikum Hannover-Siloah

    Hanover, 30449

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • SLK-Kliniken GmbH Heilbronn

    Heilbronn, 74078

  • Universitätskliniken des Saarlandes

    Homburg, 66421

  • Städtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Universitätsklinikum Kiel

    Kiel, 24116

  • Caritas-Krankenhaus Lebach

    Lebach, 66822

  • Klinikum Lippe-Lemgo

    Lemgo, 32657

  • Klinikum Lüdenscheid

    Lüdenscheid, 58515

  • Universitätsklinikum der Otto-von Guericke Universität Magdeburg

    Magdeburg, 39120

  • Klinikum der Johannes Gutenberg Universität Mainz

    Mainz, 55131

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Klinikum Schwabing

    München, 80804

  • Klinikum rechts der Isar München

    München, 81675

  • Lukaskrankenhaus GmbH Neuss

    Neuss, 41464

  • Ortenau Klinikum Offenburg Gengenbach

    Offenburg, 77654

  • Klinikum Oldenburg gGmbH

    Oldenburg, 26133

  • Klinikum Passau

    Passau, 94032

  • Caritas-Klinik St. Theresia Saarbrücken

    Saarbrücken, 66113

  • Stauferklinikum Schwäbisch Gmünd

    Schwäbisch Gmünd, 73557

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgart, 70174

  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176

  • Klinikum Traunstein

    Traunstein, 83278

  • Krankenhaus der Barmherzigen Brüder

    Trier, 54292

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78050

  • Helios Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

Austria7 sites

  • Medizinische Universitäts Graz

    Graz, 8036

  • Universitätsklinikum Innsbruck

    Innsbruck, A-6020

  • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

    Linz, A-4010

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, A-4010

  • Krankenhaus der Elisabethinen Linz

    Linz, A-4020

  • Salzburger Landeskliniken

    Salzburg, A-5020

  • Hanuschkrankenhaus Wien

    Vienna, A-1140

Other trials in Austria

About this study

Official title: Phase III Study of Chemotherapy in Combination With ATRA With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia and NPM1 Gene Mutation

Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation.

Before Amendment No. 4 (December 2013):

Read more

Primary Efficacy Objective:

  • Evaluation of efficacy based on event-free survival (EFS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1)

After Amendment No. 4 (December 2013):

Primary Efficacy Objective:

  • Evaluation of efficacy based on overall survival (OS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1)
Being tested
Gemtuzumab Ozogamicin (Mylotarg), standard chemotherapy
Keywords
adult patients, NPM1 mutation
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.

  • Gemtuzumab Ozogamicin (Mylotarg)Drug

    Induction Cycle 1, 2: GO 3mg/m² by intravenous infusion (IVI) on day 1 (total dose 3 mg/m2). Start after etoposide IVI. No dose reduction is foreseen in elderly (> 60 yrs) patients.

    Consolidation 1: GO 3mg/m² by intravenous infusion (IVI) on day 1 (total dose 3 mg/m2). Start after first dose of high-dose cytarabine. No dose reduction is foreseen in elderly (> 60 yrs) patients.

    For all patients experiencing prolonged thrombocytopenia CTC-Grade 3/4 during the first or second induction therapy, which occurs for more than day 35 after start of the cycle, the further cycles of therapy will be administered without Gemtuzumab ozogamicin.

    Consolidation 2, 3: no GO

  • standard chemotherapyDrug

    Idarubicin, Etoposide, Cytarabine, ATRA, Pegfilgrastim

Study groups in NCT00893399
Study groupRoleWhat they receive
1Experimentalchemotherapy in combination with ATRA with gemtuzumab ozogamicin
Receives: Drug: Gemtuzumab Ozogamicin (Mylotarg); Drug: standard chemotherapy
2Active comparatorchemotherapy in combination with ATRA without gemtuzumab ozogamicin
Receives: Drug: standard chemotherapy

What is being measured

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

  1. Overall survival (OS)

    Measured: four years

Secondary outcomes (8)

  1. Rates of complete remission after induction therapy (CR)

    Measured: not later than 56 days

  2. Cumulative incidences of relapse (CIR) and death in CR (CID)

    Measured: four years

  3. Event-free survival (EFS)

    Measured: four years

  4. Days in hospital during each cycle and during the whole intervention

    Measured: 6 months

  5. Type, frequency, severity, timing and relatedness of AEs and laboratory abnormalities observed during different treatment cycles

    Measured: 6 months

  6. Incidence of infection after induction and consolidation therapy

    Measured: 6 months

  7. Duration of neutropenia and thrombocytopenia after induction and consolidation therapy

    Measured: 6 months

  8. Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al [49]

    Measured: two years after completion of therapy

Timeline

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

  1. First posted6 May 2009 (estimated)
  2. Study start12 May 2010
  3. Primary completion1 Sep 2021
  4. Study completion1 Sep 2021

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
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00893399
Sponsor's protocol ID
AMLSG 09-09
Status last verified
Feb 2023
First submitted
5 May 2009
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Miah K, Goeman JJ, Putter H, Kopp-Schneider A, Benner A. Variable Selection via Fused Sparse-Group Lasso Penalized Multi-state Models Incorporating Molecular Data. Biom J. 2025 Dec;67(6):e70087. doi: 10.1002/bimj.70087.

    PubMed 41146443

  • Dohner H, Weber D, Krzykalla J, Fiedler W, Kuhn MWM, Schroeder T, Mayer K, Lubbert M, Wattad M, Gotze K, Fransecky L, Koller E, Wulf G, Schleicher J, Ringhoffer M, Greil R, Hertenstein B, Krauter J, Martens UM, Nachbaur D, Samra MA, Machherndl-Spandl S, Basara N, Leis C, Schrade A, Kapp-Schwoerer S, Cocciardi S, Bullinger L, Thol F, Heuser M, Paschka P, Gaidzik VI, Saadati M, Benner A, Schlenk RF, Dohner K, Ganser A; German-Austrian AML Study Group. Intensive chemotherapy with or without gemtuzumab ozogamicin in patients with NPM1-mutated acute myeloid leukaemia (AMLSG 09-09): a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2023 Jul;10(7):e495-e509. doi: 10.1016/S2352-3026(23)00089-3. Epub 2023 May 12.

    PubMed 37187198

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemtuzumab Ozogamicin (Mylotarg) and standard chemotherapy in people with Acute Myeloid Leukemia, run by University of Ulm at 60 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 10 inclusion and 20 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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?

Overall survival (OS) (time frame: four 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 NCT00893399, which also lists 2 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 27 Feb 2023.

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