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Acute Myeloid Leukemia (AML)Phase 1/2NCT00850382

Dasatinib (Sprycel™) in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

A Phase 1/2 study testing Dasatinib, daunorubicin and Cytarabine in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 50 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 Phase Ib/IIa open-labeled multi-center trial evaluating the feasibility of dasatinib given after standard induction therapy with daunorubicin (DNR) and cytarabine (ARA-C), after consolidation therapy with high-dose cytarabine (HDAC), and as single agent in a one-year maintenance therapy in patients with… 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, daunorubicin and Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
50 sitesin 2 countries
Study dates
Jun 2009to Nov 2015
Phase
Phase 1/2
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) (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.
  • Age ≥ 18; there is no upper age limit.
  • No prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the diag-nostic 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 poten-tial (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. 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 con-tact with women of childbearing potential while taking dasatinib and for 4 weeks 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
  • Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
Show all 9Show fewer
  • Known positive for HIV
  • Bleeding disorder independent of leukemia
  • No consent for registration, storage and processing of the individual disease-characteristics and course

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

Germany45 sites

  • Ubbo-Emmius Klinik Aurich

    Aurich, 26603

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, 53105

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114

  • Klinikum Bremen-Mitte gGmbH

    Bremen, 28177

  • Klinikum Darmstadt

    Darmstadt, 64283

  • Universitätsklinikum Duesseldorf

    Düsseldorf, 40225

  • Kliniken Essen-Sued

    Essen, 45239

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Städtische Kliniken Frankfurt Höchst

    Frankfurt-Höchst, 65929

  • Medizinische Universitätsklinik

    Freiburg im Breisgau, 79106

  • Medizinisches Versorgungszentrum Osthessen GmbH

    Fulda, 36043

  • Klinik der Justus Liebig Universität

    Giessen, 35385

  • Wilhelm- Anton- Hospital gGmbH

    Goch, 47574

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Evangelisches Krankenhaus Hamm

    Hamm, 59063

  • Klinikum Hanau gGmbH

    Hanau, 63450

  • Klinikum Hannover Siloah

    Hanover, 30449

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Universitätsklinikum des Saarlandes

    Homburg Saar, 66424

  • Staedtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • Staedtisches Krankenhaus Kiel GmbH

    Kiel, 24116

  • Caritas Krankenhaus Lebach

    Lebach, 66822

  • Klinikum Lippe-Lemgo

    Lemgo, 32657

  • Klinikum Luedenscheid

    Lüdenscheid, 58515

  • Univ-Klinikum der Otto- von Guericke- Universität

    Magdeburg, 39120

  • Universitätsklinikum der Johannes Gutenberguniversität Mainz

    Mainz, 55131

  • Johannes Wesling Klinikum

    Minden, 32429

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Klinikum Passau

    Passau, 94032

  • Elisabeth Krankenhaus

    Recklinghausen, 45661

  • Krankenhaus der Barmherzigen Brueder

    Regensburg, 93049

  • Caritas-Klinik St. Theresia

    Saarbrücken, 66113

  • Klinikum Sindelfingen-Böblingen

    Sindelfingen, 71065

  • Klinikum Stuttgart

    Stuttgart, 70174

  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

  • Medizinische Universitätsklinik Tuebingen

    Tübingen, 72076

  • Universitätsklinik Ulm

    Ulm, 89081

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78050

  • Helios Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

Austria5 sites

  • Universitätsklinikum Innsbruck

    Innsbruck, 6020

  • Krankenhaus der Barmherzigen Schwestern

    Linz, 4010

  • Elisabethinen Krankenhaus

    Linz, 4020

  • Landeskliniken Salzburg

    Salzburg, 5020

  • Hanuschkrankenhaus Wien

    Vienna, 1140

Other trials in Austria

About this study

Official title: Open-Label, Multicenter Phase Ib/IIa Study For the Evaluation of Dasatinib (Sprycel™) Following Induction and Consolida-tion Therapy as Well as in Maintenance Therapy in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

This is a Phase Ib/IIa open-labeled multi-center trial evaluating the feasibility of dasatinib given after standard induction therapy with daunorubicin (DNR) and cytarabine (ARA-C), after consolidation therapy with high-dose cytarabine (HDAC), and as single agent in a one-year maintenance therapy in patients with newly diagnosed CBF AML.

82 patients with newly diagnosed CBF AML will be enrolled at AMLSG study centers.

All AML patients will be assessed for the CBF fusion genes via the central laboratory of the AMLSG within 48 hours of diagnosis of AML, and only patients with CBF AML will be enrolled into the study.

Being tested
Dasatinib, daunorubicin, Cytarabine
Keywords
CBF 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

    Induction cycle(s):

    Dasatinib 100 mg QD on days 8-21.

    Consolidation Cycles 1, 2, 3, 4:

    Patients will receive dasatinib 100 mg QD on days 6-28.

    Maintenance therapy:

    Patients completing consolidation therapy will continue to receive single agent dasatinib 100 mg QD for one year (or until relapse).

  • daunorubicinDrug

    Induction cycle(s):

    Daunorubicin 60 mg/m2/day administered on days 1 through 3

  • CytarabineDrug

    Induction cycle(s):

    Cytarabine 200 mg/m2/day administered by continuous IV infusion daily for 7 days (days 1 through 7).

    Consolidation cycles 1, 2, 3, 4:

    Consolidation therapy consists of high-dose cytarabine 3 g/m2 (>60 years: 1 g/m2) q12h, d 1, 3, 5, administered intravenously over three hours.

Study groups in NCT00850382
Study groupRoleWhat they receive
DasatinibExperimentalInduction cycle(s): Patients will receive in cycle 1 induction therapy with daunorubicin 60 mg/m2/day administered on days 1 through 3 and cytarabine 200 mg/m2/day administered by continuous IV infusion daily for 7 days (days 1 through 7). Patients will receive dasatinib 100 mg QD on days 8-21. Patients not achieving CR or CRi at the end of cycle 1 will be evaluable to receive a second induction cycle identical in schedule and dosage to the first induction cycle. Consolidation Cycles 1, 2, 3, 4: Patients achieving CR or CRi at the end of cycle 1 will receive consolidation therapy for 4 cy-cles. Consolidation therapy consists of high-dose cytarabine 3 g/m2 (>60 years: 1 g/m2) q12h, d 1, 3, 5, administered intravenously over three hours. Patients will receive dasatinib 100 mg QD on days 6-28. 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: daunorubicin; Drug: Cytarabine

What is being measured

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

  1. Feasibility as combined endpoint: Rate of ED/HD Rate of pleural/pericardial effusion grade 3/4 Rate of liver toxicity grade 3/4 that does not improve to <= grade 2 within 14 days after discontinuing responsible medication Rate of refractory disease

    Measured: after 4 weeks

Secondary outcomes (2)

  1. Cumulative incidence of relapse (CIR) and death (CID)

    Measured: After follow-up period of two years

  2. Overall survival (os)

    Measured: After follow-up period of 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 posted25 Feb 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionNov 2015
  4. Study completionNov 2015

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00850382
Sponsor's protocol ID
AMLSG 11-08
Status last verified
Feb 2016
First submitted
23 Feb 2009
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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 1/2 study testing Dasatinib, daunorubicin and Cytarabine in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 50 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 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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?

Feasibility as combined endpoint: Rate of ED/HD Rate of pleural/pericardial effusion grade 3/4 Rate of liver toxicity grade 3/4 that does not improve to <= grade 2 within 14 days after discontinuing responsible medication Rate of refractory disease (time frame: after 4 weeks). 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 NCT00850382, which also lists 1 linked publication.

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 1 Mar 2016.

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