European Leukemia Trial Registry
Trial: AMLSG 15-10

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Public Title Randomized Phase III Study of Low-Dose Cytarabine and Etoposide with or without All-Trans Retinoic Acid in Older Patients not Eligible for Intensive Chemotherapy with Acute Myeloid Leukemia and NPM1 Mutation
Scientific Title Randomized Phase III Study of Low-Dose Cytarabine and Etoposide with or without All-Trans Retinoic Acid in Older Patients not Eligible for Intensive Chemotherapy with Acute Myeloid Leukemia and NPM1 Mutation
Short Title AMLSG 15-10
Id KN/ELN LN_AMLSGU_2011_399
Trialgroup AMLSG Ulm
Type of Trial multicentric, randomized, open-label
Phase Phase III
Disease Acute myeloid leukemia(AML) AML all subtypes without FAB M3
Stage of Disease de novo/non-treated - Therapy concepts for specific genotypes - >= 60 years
Molecular Marker NPM1
Aim
  • Evaluation of overall survival after treatment with low-dose cytarabine and etoposide with or without all-trans retinoic acid (ATRA) in patients with acute myeloid leukemia (AML) and nucleophosmin-1 (NPM1) mutation ineligible for intensive treatment
  • Evaluation of efficacy based on complete remission (CR) rates, event-free survival (EFS), and cumulative incidences of relapse and deaths in CR
Inclusion Criteria
  • Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML)
  • Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
  • Age > 60 years. There is no upper age limit.
  • No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 10 days during the diagnostic screening phase.
  • Signed written informed consent
  • Men must give their informed consent that they do not father a baby and must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy while on therapy and for 3 month after the last dose of chemotherapy.
  • WHO performance status ≤ 3
  • Patients not eligible for intensive chemotherapy according to at least one of the following criteria
  • - HCT-CI Score >2 (see Appendix F)
  • - Patient¡¯s decision
  • - age ≥ 75 years
Exclusion Criteria
  • All other AML subtypes, in particular those 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
  • - AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
  • No consent for registration, storage and processing of the individual diseasecharacteristics and course as well as information of the family physician and all other treating physicians about study participation
  • Bleeding disorder independent of leukemia
  • Uncontrolled infection
  • Known positive for HIV, HBV or HCV
  • 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)
  • 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.
Age > 60 years
Status No longer recruiting
Start of Recruitment 01.01.2011
Recruiting Countries Germany
Austria
Target Sample Size 144
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
Institut für Humangenetik, Medizinische Hochschule Hannover (MHH)

Testmethod
Hämatologie, Hämostaseologie, Onkologie Hannover

Sponsors Ulm University Hospital (Main Sponsor)
Supporters Bundesministerium für Bildung und Forschung
Other Registers ClinicalTrials.gov NCT01237808
Outcomes
  • Gesamtüberleben Overall Survival (OS)
  • Rate an kompletten Remissionen nach der Induktionstherapie CR) Rates of CR
  • Kumulative Inzidenzen an Rezidiven (CIR) und Todesfällen in CR (CID) Cumulative incidences of relapse (CIR) and death in CR (CID)
  • Ereignisfreies Überleben Event-free survival (EFS)
created 08.12.2010 Johannes Kraus
changed 21.02.2017 Eva-Maria Ableidinger
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