A trial to test the effect of BL-8040 or placebo given to AML patients in addition to standard treatment in masked manner.
- Conditions
- consolidation therapy in acute myeloid leukemia in first complete remissionMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2014-002702-21-DE
- Lead Sponsor
- Martin-Luther-Universität Halle- Wittenberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 194
1.Subjects must be at least 18 years old at the time of registration
2.Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia).
3.Subjects with AML who achieved complete remission (CR), including CRi and CRp after a maximum number of two cycles of induction chemotherapy (must contain at the minimum cytarabine as well as an anthracycline or mitoxantrone). CR (or CRi or CRp) needs to be confirmed by bone marrow aspirate up to 7 days prior to randomization.
4.AML subjects younger than 60 yearswith intermediate or high-risk cytogenetics at the time of diagnosis
5.60 years old AML subjects and older at the time of diagnosis can be enrolled into the trial independent of cytogenetics or molecular genetic risk group.
6.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
7.Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of =2 at screening
8.The clinical laboratory values should be as follows (at screening):
- 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)
9. 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)].
Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide) or abstinence during the study.
10.Subject is able and willing to comply with the requirements of the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1.Relapsed or refractory AML
2.Start of induction cycle > 90 days before randomization.
3.Subjects who have received >2 cycles of induction chemotherapy for AML therapy.
4.Subjects younger than 60 years 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 at the time of diagnosis .
5.Subjects for which allogeneic HSCT is planned in CR1. If subject refuses HSCT, participation is allowed.
6.Subjects planned for a further maintenance therapy after the end of the protocol defined consolidation therapy.
7.Known allergic or hypersensitivity to BL-8040- or Cytarabine or to any of the test compounds, materials
8.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 / observational studies are permissible.
9.Abnormal liver function tests:
- Serum AST/ GOT or ALT/ GPT > 3x upper limit of normal (ULN)
- Serum bilirubin: Total bilirubin > 2.0mg/dl or conjugated bilirubin > 0.8mg/dl
10.O2 saturation < 92% (on room air)
11.Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
•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.
•A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
•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
•Active, uncontrolled infection.
• The participation of subject´s receiving long acting insulin (with high protein binding) and oral antidiabetic agents should be weighed by the investigator due to increased susceptibility of hypoglycaemia. If such patients are enrolled, an increased frequency of blood glucose monitoring is required.
12.Prior clinically significant grade 3-4 non-hematological toxicity to high-dose cytarabine or grade = 2 of neurological toxicity
13.Positive serology for HIV, active Hepatitis C and Hepatitis B (HBsAG pos.).Serology must be performed within 2 months before Randomization..
14.Left ventricular ejection fraction (LVEF) of <40% by echocardiogram (ECHO) at screening.
15.Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method