European Leukemia Trial Registry
Trial: AMLSG 11-08

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Public Title Phase Ib/IIa Study For the Evaluation of Dasatinib Following Induction and Consolidation Therapy as well as in Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML
Scientific Title Open-Label, Multicenter Phase Ib/IIa Study For the Evaluation of Dasatinib (Sprycel™) Following Induction and Consolidation Therapy as well as in Maintenance Therapy in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML
Short Title AMLSG 11-08
Id KN/ELN LN_AMLSGU_2009_314
Trialgroup AMLSG Ulm
Type of Trial multicentric, open-label
Phase Phase I/II
Disease Acute myeloid leukemia(AML) AML all subtypes without FAB M3
Stage of Disease de novo/non-treated - Therapy concepts for specific genotypes - All age groups
Aim
  • To assess the feasibility of dasatinib 100 mg QD given after intensive induction (daunorubicin and cytarabine) and consolidation chemotherapy (high-dose cytarabine) and as single agent in maintenance therapy
  • To assess survival endpoints such as cumulative incidence of relapse (CIR) and death (CID), and overall survival (OS
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 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 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 contact 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)
  • 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 as well as information of the family physician about study participation
Age >= 18 years
Status Closed
Start of Recruitment 03.09.2009
Recruiting Countries Germany
Austria
Target Sample Size 82
Leader Döhner, Prof. Dr. med., Hartmut
Scientific Contact Döhner, Prof. Dr. med., Hartmut (Affliliation)
Contact Person

Biometrics
Benner, A.
Tel: +49 (0)6221 422390
Fax: +49 (0)6221 422397
Email: benner@dkfz-heidelber.de
Homepage: www.dkfz.de

Study Centre
Weber, Daniela
Tel: +49 (0)731 50056072
Fax: +49 (0)731 50045905
Email: aml.sekretariat@uniklinik-ulm.de

Shortprotocol Shortprotocol
Diagnostics

Molecular Genetics
Labor für Zytogenetische und Molekulargenetische Diagnostik, Klinik für Innere Med. III, Universitätsklinikum Ulm
Labor für Leukämieforschung der Medizinischen Hochschule Hannover

Sponsors Ulm University Hospital
Supporters Bristol-Myers Squibb
Other Registers ClinicalTrials.gov NCT00850382 (primary Register)
Outcomes
  • Rate of early/hypoplastic death (Rate(ED/HD))<10%
  • Rate of pleural or pericardial effusion grade 3/4 (Rate(effuse))<10%
  • Rate of liver toxicity grade 3 or 4 that does not improve to grade 2 or less within 14 days after discontinuing responsible medication (Rate(liver))<10%
  • Rate of refractory disease (Rate(RD))<10%
  • Cumulative incidence of relapse (CIR) and death CID)
  • Overall survival (OS)
created 06.10.2009 Roswitha Kotthoff
changed 24.07.2017 Eva-Maria Ableidinger
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