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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00850382
Other study ID # AMLSG 11-08
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 23, 2009
Last updated February 29, 2016
Start date June 2009
Est. completion date November 2015

Study information

Verified date February 2016
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Known positive for HIV

- Bleeding disorder independent of leukemia

- No consent for registration, storage and processing of the individual disease-characteristics and course

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Dasatinib
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).
daunorubicin
Induction cycle(s): Daunorubicin 60 mg/m2/day administered on days 1 through 3
Cytarabine
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.

Locations

Country Name City State
Austria Universitätsklinikum Innsbruck Innsbruck
Austria Elisabethinen Krankenhaus Linz
Austria Krankenhaus der Barmherzigen Schwestern Linz
Austria Landeskliniken Salzburg Salzburg
Austria Hanuschkrankenhaus Wien Wien
Germany Ubbo-Emmius Klinik Aurich Aurich
Germany Charité Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Bonn Bonn
Germany Städtisches Klinikum Braunschweig Braunschweig
Germany Klinikum Bremen-Mitte gGmbH Bremen
Germany Klinikum Darmstadt Darmstadt
Germany Universitätsklinikum Duesseldorf Duesseldorf
Germany Kliniken Essen-Sued Essen
Germany Klinikum Esslingen Esslingen
Germany Städtische Kliniken Frankfurt Höchst Frankfurt-Höchst
Germany Medizinische Universitätsklinik Freiburg
Germany Medizinisches Versorgungszentrum Osthessen GmbH Fulda
Germany Klinik der Justus Liebig Universität Gießen
Germany Wilhelm- Anton- Hospital gGmbH Goch
Germany Universitätsmedizin Göttingen Göttingen
Germany Asklepios Klinik Altona Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Evangelisches Krankenhaus Hamm Hamm
Germany Klinikum Hanau gGmbH Hanau
Germany Klinikum Hannover Siloah Hannover
Germany Medizinische Hochschule Hannover Hannover
Germany SLK-Kliniken Heilbronn GmbH Heilbronn
Germany Universitätsklinikum des Saarlandes Homburg Saar
Germany Staedtisches Klinikum Karlsruhe Karlsruhe
Germany Staedtisches Krankenhaus Kiel GmbH Kiel
Germany Caritas Krankenhaus Lebach Lebach
Germany Klinikum Lippe-Lemgo Lemgo
Germany Klinikum Luedenscheid Luedenscheid
Germany Univ-Klinikum der Otto- von Guericke- Universität Magdeburg
Germany Universitätsklinikum der Johannes Gutenberguniversität Mainz Mainz
Germany Johannes Wesling Klinikum Minden
Germany Klinikum rechts der Isar der TU Muenchen Muenchen
Germany Klinikum Oldenburg Oldenburg
Germany Klinikum Passau Passau
Germany Elisabeth Krankenhaus Recklinghausen
Germany Krankenhaus der Barmherzigen Brueder Regensburg
Germany Caritas-Klinik St. Theresia Saarbrücken
Germany Klinikum Sindelfingen-Böblingen Sindelfingen
Germany Diakonie-Klinikum Stuttgart Stuttgart
Germany Klinikum Stuttgart Stuttgart
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Germany Medizinische Universitätsklinik Tuebingen Tuebingen
Germany Universitätsklinik Ulm Ulm
Germany Schwarzwald-Baar Klinikum Villingen-Schwenningen
Germany Helios Klinikum Wuppertal Wuppertal

Sponsors (1)

Lead Sponsor Collaborator
University of Ulm

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 after 4 weeks Yes
Secondary Cumulative incidence of relapse (CIR) and death (CID) After follow-up period of two years Yes
Secondary Overall survival (os) After follow-up period of two years No
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