NCT02502968

Brief Summary

This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

2.8 years

First QC Date

July 6, 2015

Last Update Submit

September 18, 2015

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Relapse Free Survival time

    Relapse is defined as recurrence of leukemic blasts (more than 5%) in the bone marrow after confirmed complete remission

    18 months

Secondary Outcomes (6)

  • Overall Survival

    18 months

  • Time to relapse

    18 months

  • Relapse free survival

    6, 9, 12 and 18 months

  • Relapse

    6, 9, 12 and 18 months

  • Minimal residual disease

    6, 9, 12 and 18 months

  • +1 more secondary outcomes

Study Arms (2)

Cytarabine & BL8040

EXPERIMENTAL

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

Drug: CytarabineDrug: BL-8040

Cytarabine & Placebo

ACTIVE COMPARATOR

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

Drug: CytarabineDrug: Placebo (for BL-8040)

Interventions

CytarabineDRUG
Cytarabine & BL8040Cytarabine & Placebo
BL-8040DRUG
Cytarabine & BL8040
Placebo (for BL-8040)DRUG

Powder for solution for injection manufactured to mimic BL-8040

Cytarabine & Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeritätsklinikum Halle, Klinik Innere Medizin 4

Halle, 06120, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine4-fluorobenzoyl-TN-14003

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Carsten Müller-Tidow, MD

    University Hospital Halle, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Kowoll, MSc

CONTACT

+49-345-5574908blast@kks-halle.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 20, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2018

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations

DE(1)