Deutsches Leukämie-Studienregister
Studie: BLAST

Kurzübersicht
Öffentlicher Titel Phase II Wirksamkeitsstudie zu BL-8040 bei AML
Wissenschaftl. Titel Doppelblinde, Placebo-kontrollierte, randomisierte, multizentrische Phase II Studie zur Beurteilung der Wirksamkeit von BL-8040 in der Konsolidierungstherapie bei AML
Kurztitel BLAST
Studiennummer KN/ELN LN_OSHOSA_2016_598
Studiengruppe OSHO/SAL
Studienart multizentrisch, randomisiert, doppelblind, zweiarmig
Studienphase Phase II
Erkrankung Akute myeloische Leukämie (AML) - AML alle außer FAB M3
Leukämiestadium de novo/non-treated - Genotyp-spezifische Therapiekonzepte - Alle Altersgruppen
Ziele
  • to compare Relapse Free Survival (RFS) of subjects receiving BL-8040 compared to placebo, on top of standard consolidation therapy in subjects with AML
  • to compare overall survival (OS)
  • time to relapse in the treatment groups
  • to report RFS in the treatment groups at 6, 9, 12 and 18 months after randomization
  • to compare RFS and OS of AML subjects between treatment groups in the two subgroups according to different cytogenetic and molecular risk
  • to report the Minimal residual disease (MRD; LSC rate) (by FACS at baseline, end of study treatment (EOT), 6, 9, 12 and study termination/early study termination visit (ST/EST) (month 18/EST)
  • to assess the toxicity, safety and tolerability of BL-8040 in combination with high-dose cytarabine
  • to report the incidence of Early Treatment termination
  • to report the incidence of Early Study termination (18 months)
  • to report the incidence of Early Treatment termination due to adverse events
Einschlusskriterien
  • Subjects must be between 18 and 75 years old, both inclusive, at the time of screening
  • Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia).
  • Subjects with AML who achieved complete remission (CR), including CRi and CRp after a maximum number of two cycles of induction chemotherapy. CR (or CRi or CRp) needs to be confirmed by bone
  • AML subjects younger than 60 years at the time of diagnosis with intermediate or high-risk cytogenetics
  • 60 years old AML subjects and older but <= 75 years at the time of diagnosis can be enrolled into the trial independent of cytogenetics or molecular genetic risk group.
  • Subjects must provide written informed consent at screening, prior to performance any study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of AML, and the subjects must be willing to comply with treatment and to follow up assessments and procedures
  • The clinical laboratory values should be as follows (at time of randomization): WBC < 30.000/µl and > 1000/µl; Platelets count > 70.000/µl; Creatinine < 1.0 mg/dl. If creatinine is between 1.0mg/dl and 1.3mg/dl, the creatinine clearance should be > 30ml/min as calculated using the Cockroft-Gault formula (See appendix 17.4)
  • Women of child-bearing potential must practice an acceptable method of birth control until 6 month after the last dose of treatment was administered [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive or double-barriermethod (condom or diaphragm with spermicide)].
  • Subject is able and willing to comply with the requirements of the protocol
Ausschlusskriterien
  • Relapsed or refractory AML
  • Start of induction cycle > 90 days before randomization.
  • Subjects who have received >2 cycles of induction chemotherapy for AML therapy.
  • Subjects younger than 60 years at the time of diagnosis with favorable cytogenetics (t(8;21) or inv(16) or t(16;16) or t(15;17)) or the confirmed presence of the resulting fusion protein AML1-ETO, CBFB-MYH11 or PML-RARA.
  • Subjects planned for a further maintenance therapy after the end of the protocol defined consolidation therapy.
  • Known allergic or hypersensitivity to BL8040- or Cytarabine or to any of the test compounds, materials
  • Use of investigational device or agents within 2 weeks or less than 5 half lifes for each investigational product /device at the time of enrollment. Subjects be treated with an experimental drug for two weeks before randomization. Subjects cannot take part in other clinical trials starting from screening. Registry studies are permissible.
  • Abnormal liver function tests: Serum AST/ GOT or ALT/ GPT > 3x upper limit of normal (ULN); Serum bilirubin: Total bilirubin > 2.0mg/dl, conjugated bilirubin > 0.8mg/dl
  • O2 saturation < 92% (on room air)
  • Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to: (a) Subject has been diagnosed or treated for another malignancy within 3 years of enrollment, except in situ malignancy, or low-risk prostate, skin or cervical cancer after curative therapy. History of other cancer that according to the Investigator might confound the assessment of the endpoints of the study; (b) A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications; (c) History of any or more of the following cardiovascular conditions: cardiac angioplasty (within 6 months) or stenting (within 6 months) and/or myocardial infarction (MI) (within 6 months) or cerebro-vascular event within the past 6 months, unstable angina, vascular disease, class III or IV, congestive heart failure (as defined by the New York Heart Association (NYHA)) Known central nervous system disease that may jeopardize the subject’s study participation according to the investigator judgement; (d) Active, uncontrolled infection.
  • Prior clinically significant grade 3-4 non-hematological toxicity to high-dose cytarabine or grade >= 2 of neurological toxicity
  • Positive serology for HIV, active Hepatitis C and Hepatitis B (HBsAG pos.) at baseline
  • Left ventricular ejection fraction (LVEF) of <40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) at baseline
  • Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Alter 18 - 75 Jahre
Status Aktiv
Beginn der Rekrutierung 01.01.2016
Fallzahl 197
Studienleiter/in Müller-Tidow, Prof. Dr. med., Carsten
Kontaktperson f.
wissenschaftl. Anfragen
Müller-Tidow, Prof. Dr. med., Carsten
Ansprechpartner

Organisatorische Anfragen
Kowoll, Simone
Tel: +49 (0)345 5574908
E-Mail: blast@kks-halle.de

Studienkoordination
Wass, Dr., Maxi
Tel: +49 (0)345 5573005
E-Mail: maxi.wass@uk-halle.de

Kurzprotokoll Kurzprotokoll
Sponsoren Martin-Luther Universität Halle
Registrierung in anderen Studienregistern European Clinical Trials Database - EUDRACT 2014-002702-21
erstellt 11.10.2016 Student Studienregister
geändert 18.10.2016 Student Studienregister
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