AzTrials
AzTrials

Acute Myeloid Leukemia (AML)Phase 3NCT02013648

Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)

A Phase 3 study testing Dasatinib, Cytarabine and Daunorubicin in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 54 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 is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Dasatinib, Cytarabine and Daunorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
54 sitesin 2 countries
Study dates
Jul 2014to Feb 2024
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

  • Core-binding factor (CBF) AML with molecular diagnosis of RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22.1) (or a variant form) or of CBFB-MYH11 fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) as assessed in one of the central AMLSG reference laboratories (Ulm, Hannover)
  • Age ≥ 18; there is no upper age limit
  • No prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the diagnostic screening phase
  • Non-pregnant and non-nursing. Due to the unknown teratogenic potential of dasatinib in humans, pregnant or nursing patients may not be enrolled. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL with-in 72 hours prior to registration. 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) - AT THE SAME TIME, at least four weeks before she begins dasatinib therapy. "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 agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking dasatinib and for 3 months after therapy is stopped, even if they have undergone a successful vasectomy.
  • Signed written informed consent.

Who cannot join

  • Performance status WHO >2
  • Pulmonary edema and/or pleural/pericardial effusion within 14 days of day 1. If edema/effusion resolves to CTC Grade ≤1, patients can be treated with dasatinib.
  • Patients with ejection fraction <50% by echocardiography within 14 days of day 1
  • Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or AP >2.5x upper normal serum level; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
  • Uncontrolled infection
  • 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.
Show all 11Show fewer
  • Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
  • 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 and/or other physicians involved in the treatment of the patient about study participation.
  • No consent for biobanking.

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

Germany49 sites

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, 63739

  • Helios Klinikum Bad Saarow, Klinik für Hämatologie

    Bad Saarow, 15526

  • Klinikum am Urban

    Berlin, 10967

  • Klinikum Neukölln

    Berlin, 12351

  • Charité Universitätsmedizin Campus Virchow Klinikum

    Berlin, 13353

  • Knappschaftskrankenhaus Bochum

    Bochum

  • Universitätsklinikum Medizinische Klinik und Poliklinik III

    Bonn, 53105

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Klinikum Bremen Mitte gGmbH

    Bremen, 28117

  • Klinikum Darmstadt Medizinische Klinik V

    Darmstadt, 64276

  • St. Johannes Hospital

    Dortmund, 44137

  • Universitätsklinikum Medizinische Klinik und Poliklinik

    Düsseldorf, 40001

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Malteser Krankenhaus St. Franziskus-Hospital

    Flensburg, 24939

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • MVZ Osthessen

    Fulda, Hesse, 36043

  • Wilhelm-Anton-Hospital gGmbH

    Goch, 47574

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Klinikum Hanau GmbH

    Hanau, 63450

  • Klinikum Region Hannover GmbH

    Hanover, 30449

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • SLK-Kliniken GmbH

    Heilbronn, 74078

  • Marienhospital Klinikum der Ruhr-Universität

    Herne, 44625

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Städtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24116

  • Gemeinschaftspraxis Hämato-Onkologie

    Lebach, 66822

  • Klinikum Lippe GmbH

    Lemgo, 32657

  • Märkische Kliniken GmbH

    Lüdenscheid, 58515

  • Univ-Klinikum der Otto-von Guericke-Universität

    Magdeburg, 39120

  • III. Medizinische Klinik und Poliklinik Universitätsmedizin der Johannes Gutenberg-Universität

    Mainz, 55131

  • Johannes Wesling Klinikum

    Minden, 32429

  • Klinikum rechts der Isar der TU

    München, 81675

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557

  • Ortenau Klinikum

    Offenburg, 77654

  • PIUS Hospital

    Oldenburg, 26121

  • Klinikum Oldenburg gGmbH

    Oldenburg, 26133

  • Klinikum Passau

    Passau, 94032

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Caritasklinkum Saarbrücken St. Theresia

    Saarbrücken, 66113

  • Klinikum Stuttgart

    Stuttgart, 70174

  • Vinzenz von Paul Kliniken gGmbH Marienhospital

    Stuttgart, 70199

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290

  • Medizinische Universitätsklinik

    Tübingen, 72076

  • Universitätsklinikum Ulm Zentrum für Innere Medizin

    Ulm, 89081

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78052

  • Kliniken Essen Süd

    Werden, 45239

  • HELIOS Klinikum

    Wuppertal, 42283

Other trials in Germany

Austria5 sites

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020

  • Krankenhaus der Barmherzigen Schwestern

    Linz, 4010

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, 4020

  • Universitätsklinik der PMU

    Salzburg, 5020

  • Hanuschkrankenhaus

    Vienna, 1140

Other trials in Austria

About this study

Official title: Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™) in Adult Patients With Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML

Read the detailed description

This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML; in the investigational arm, consolidation therapy is followed by a one-year maintenance therapy with dasatinib. Patients with molecular disease persistence or molecular relapse as assessed by quantitative RQ-PCR for the CBF fusion transcripts will be eligible for hematopoietic stem cell transplantation before overt hematologic relapse occurs. Primary endpoint is event-free survival.

AML patients will be assessed for the CBF fusion genes in one of two AMLSG central laboratories within 48 hours of diagnosis, and only patients with CBF-AML will be enrolled.

Being tested
Dasatinib, Cytarabine, Daunorubicin, Idarubicin
Keywords
AML, Dasatinib, Core Binding Factor (CBF)
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.

  • DasatinibDrug

    Also called Sprycel

  • CytarabineDrug

    Also called ARA-cell

  • DaunorubicinDrug

    Also called Daunoblastin

  • IdarubicinDrug

Study groups in NCT02013648
Study groupRoleWhat they receive
Standard armActive comparatorPatients will receive induction therapy with daunorubicin 60 mg/m2/day administered on days 1-3 (when daunorubicin is not available due to supply shortage: Idarubicin 12mg²/day on days 1,3,5) and cytarabine 200 mg/m2/day administered by continuous IV infusion on days 1-7. Patients achieving PR only at the end of cycle 1 will receive a second induction cycle with daunorubicin 50 mg/m2/day (when daunorubicin is not available due to supply shortage: Idarubicin 10 mg²/day on days 1 and 3) administered on days 1-3 and cytarabine 200 mg/m2/day administered by cont. IV infusion daily on days 1-5. Patients will receive 4 cycles of consolidation therapy. Consolidation therapy consists of high-dose cytarabine 3 g/m2 (>60 years: 1 g/m2) q12h, days 1-3 administered intravenously over three hours. Follow-up period: There is no maintenance therapy in the standard arm. Patients will be closely followed, in particular for molecular disease persistence or molecular relapse.
Receives: Drug: Cytarabine; Drug: Daunorubicin; Drug: Idarubicin
Investigational armExperimentalPatients will receive induction therapy with daunorubicin 60 mg/m2/day on days 1-3 (when daunorubicin is not available due to supply shortage: Idarubicin 12mg²/day on days 1,3,5) and cytarabine 200 mg/m2/day by cont. IV infusion on days 1-7. Patients will receive dasatinib 100 mg QD on days 8-21. Patients achieving PR only at the end of cycle 1 will receive a 2nd induction cycle with daunorubicin 50 mg/m2/day on days 1-3 (when daunorubicin is not available due to supply shortage: Idarubicin 10 mg²/day on days 1 and 3) and cytarabine 200 mg/m2/day by cont. IV infusion on days 1-5. Patients will receive dasatinib 100 mg QD on days 6-21. Consolidation therapy (4 cycles). Treatment consists of high-dose cytarabine 3 g/m2 (>60 years: 1 g/m2) q12h, days 1-3 iv over 3 hours. Patients will receive dasatinib 100 mg QD on days 4-21. Maintenance therapy: Patients completing consolidation therapy will continue to receive single agent dasatinib 100 mg QD for one year (or until relapse).
Receives: Drug: Dasatinib; Drug: Cytarabine; Drug: Daunorubicin; Drug: Idarubicin

What is being measured

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

  1. Event-free Survival

    To assess event-free survival (EFS) after intensive induction (daunorubicin and cytarabine) and consolidation (high-dose cytarabine) chemotherapy with or without dasatinib in patients with CBF-AML

    Measured: 4 years

Secondary outcomes (6)

  1. Cumulative incidence of relapse (CIR)

    Measured: 4 years

  2. Cumulative incidence of death (CID)

    Measured: 4 years

  3. overall survival

    Measured: 4 years

  4. relapse-free survival

    Measured: 4 years

  5. PIA analysis

    Pharmacodynamic inhibition of KIT as assessed by the KIT plasma inhibitory assay (PIA)

    Measured: 4 years

  6. toxicity

    Type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03), timing and relatedness of non-hematologic toxicity observed during different treatment cycles.

    Measured: 7 months (standard arm) / 19 months (investigational arm)

Timeline

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

  1. First posted17 Dec 2013 (estimated)
  2. Study startJul 2014
  3. Primary completionFeb 2024
  4. Study completionFeb 2024

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
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02013648
Sponsor's protocol ID
AMLSG 21-13
Status last verified
Feb 2024
First submitted
11 Dec 2013
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Dohner H, Spath D, Saadati M, Fiedler W, Gotze K, Koller E, Westermann J, Vogel W, Heuser M, Lubbert M, Tischler HJ, Germing U, Teichmann LL, Fransecky L, Wolfler A, Nachbaur D, Hertenstein B, Schroers R, Martens U, von Harsdorf S, Radsak M, Aschauer G, Weisshaar S, Corbacioglu A, Schrade A, Gaidzik VI, Thol F, Paschka P, Bullinger L, Benner A, Dohner K, Ganser A. A phase 3 study of intensive chemotherapy with or without dasatinib in core-binding factor acute myeloid leukemia. Blood. 2026 Apr 9;147(15):1735-1748. doi: 10.1182/blood.2025030722.

    PubMed 41490515

  • Paschka P, Schlenk RF, Weber D, Benner A, Bullinger L, Heuser M, Gaidzik VI, Thol F, Agrawal M, Teleanu V, Lubbert M, Fiedler W, Radsak M, Krauter J, Horst HA, Greil R, Mayer K, Kundgen A, Martens U, Heil G, Salih HR, Hertenstein B, Schwanen C, Wulf G, Lange E, Pfreundschuh M, Ringhoffer M, Girschikofsky M, Heinicke T, Kraemer D, Gohring G, Ganser A, Dohner K, Dohner H. Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial. Leukemia. 2018 Jul;32(7):1621-1630. doi: 10.1038/s41375-018-0129-6. Epub 2018 Apr 17.

    PubMed 29720733

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dasatinib, Cytarabine and Daunorubicin in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 54 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 6 inclusion and 11 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 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?

Event-free Survival (time frame: 4 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 NCT02013648, 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 23 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in