- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02502968
BL-8040 Addition to Consolidation Therapy in AML Patients (BLAST)
A Double- Blind, Placebo Controlled, Randomized, Multicenter, Phase II Study to Assess the Efficacy of BL-8040 Addition to Consolidation Therapy in AML Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Simone Kowoll, MSc
- Phone Number: +49-345-5574908
- Email: blast@kks-halle.de
Study Locations
-
-
-
Halle, Germany, 06120
- Recruiting
- Univeritätsklinikum Halle, Klinik Innere Medizin 4
-
Contact:
- Carsten Müller-Tidow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
- AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
- AML subjects younger than 60 years at the time of diagnosis with intermediate or high-risk cytogenetics
- ECOG performance status ≤2
- Laboratory values 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, creatinine clearance should be > 30ml/min as calculated using the Cockroft-Gault formula
- Women of child-bearing potential must practice an acceptable method of birth control until 6 month after the last dose of treatment. 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.
- Male with a female partner of childbearing potential using a barrier method of contraception
- Written informed consent
- 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 for which allogeneic HSCT is planned in CR1.
- Planned 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 enrolment. 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)
- Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
- Another malignancy within 3 years of enrolment, 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cytarabine & BL8040
Subjects ≥60 years: cytarabine 1g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 2 cycles and BL-8040 (1.25 mg/kg) subcutaneously on days 1 to 5 of each cycle Subjects <60 years: cytarabine 3g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 3 cycles and BL-8040 (1.25 mg/kg) subcutaneously on days 1 to 5 of each cycle |
|
Active Comparator: Cytarabine & Placebo
Subjects ≥60 years: cytarabine 1g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 2 cycles and Placebo (for BL-8040) subcutaneously on days 1 to 5 of each cycle Subjects <60 years: cytarabine 3g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 3 cycles and Placebo (for BL-8040) subcutaneously on days 1 to 5 of each cycle |
Powder for solution for injection manufactured to mimic BL-8040
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse Free Survival time
Time Frame: 18 months
|
Relapse is defined as recurrence of leukemic blasts (more than 5%) in the bone marrow after confirmed complete remission
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 18 months
|
18 months
|
|
Time to relapse
Time Frame: 18 months
|
18 months
|
|
Relapse free survival
Time Frame: 6, 9, 12 and 18 months
|
6, 9, 12 and 18 months
|
|
Relapse
Time Frame: 6, 9, 12 and 18 months
|
Defined as recurrence of leukemic blasts (more than 5%) in the bone marrow after confirmed complete remission
|
6, 9, 12 and 18 months
|
Minimal residual disease
Time Frame: 6, 9, 12 and 18 months
|
Immunophenotypic characterization of human bone marrow cells will be done to determine MRD
|
6, 9, 12 and 18 months
|
Toxicity
Time Frame: enitire study course until 18 months
|
Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way
|
enitire study course until 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carsten Müller-Tidow, MD, University Hospital Halle, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKH062014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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