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BL-8040 Addition to Consolidation Therapy in AML Patients

NCT02502968 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2015-09-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cytarabine

DRUG

BL-8040

DRUG

Placebo (for BL-8040)

Powder for solution for injection manufactured to mimic BL-8040

Sponsors & Collaborators

  • BioLineRx, Ltd.

    collaborator INDUSTRY

  • Dr. Petra Tschanter

    lead OTHER

Principal Investigators

  • Carsten Müller-Tidow, MD · University Hospital Halle, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02502968 on ClinicalTrials.gov