European Leukemia Trial Registry
Trial: BLAST

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Public Title Phase II Wirksamkeitsstudie zu BL-8040 bei AML
Scientific Title A double- blind, placebo controlled, randomized, multicenter, Phase II study to assess the efficacy of BL-8040 addition to consolidation therapy in AML patients
Short Title BLAST
Id KN/ELN LN_OSHOSA_2016_598
Trialgroup OSHO/SAL
Type of Trial multicentric, randomized, double-blind, double-group
Phase Phase 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 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
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
Age 18 - 75 years
Status Active
Start of Recruitment 01.01.2016
Target Sample Size 197
Leader Müller-Tidow, Prof. Dr. med., Carsten
Scientific Contact Müller-Tidow, Prof. Dr. med., Carsten (Affliliation)
Contact Person

Administrative needs
Kowoll, Simone
Tel: +49 (0)345 5574908
Email: blast@kks-halle.de

Study coordinator
Wass, Dr., Maxi
Tel: +49 (0)345 5573005
Email: maxi.wass@uk-halle.de

Shortprotocol Shortprotocol
Sponsors Martin-Luther Universität Halle
Other Registers European Clinical Trials Database - EUDRACT 2014-002702-21
created 11.10.2016 Student Studienregister
changed 18.10.2016 Student Studienregister
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