Spots Global Cancer Trial Database for FLYSYN in MRD Positive AML
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Trial Identification
Brief Title: FLYSYN in MRD Positive AML
Official Title: First in Man Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Fc-optimized FLT3 Antibody FLYSYN for the Treatment of Acute Myeloid Leukemia Patients With Minimal Residual Disease
Study ID: NCT02789254
Conditions
Interventions
Study Description
Brief Summary: This is a first in human, prospective, multicentric, nonrandomized, open-label study to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of the Fc-optimized antibody FLYSYN as monotherapy in adult subjects.
Detailed Description: Cohort 1: Patient 1-3: FLYSYN 0.5 mg/m² body surface area (BSA) day 1 Cohort 2: Patient 4-6: FLYSYN 0.5 mg/m² body surface area (BSA) day 1 FLYSYN 1.0 mg/m² BSA day 2 Cohort 3: Patient 7-9: FLYSYN 0.5 mg/m² body surface area (BSA) day 1, FLYSYN 4.5 mg/m² BSA day 2 Cohort 4: Patient 10-12 and 13-18: FLYSYN 0.5 mg/m² body surface area (BSA) day 1, FLYSYN 14.5 mg/m² BSA day 2 Cohort 5: Patient 19-21: FLYSYN 0.5 mg/m² body surface area (BSA) day 1, FLYSYN 44.5 mg/m² BSA day 2 Cohort 6: Patient 22-24 and 25 -31: FLYSYN 0.5 mg/m² body surface area (BSA) day 1, FLYSYN 14.5 mg/m² BSA day 2, FLYSYN 15 mg/m² BSA day 15, FLYSYN 15 mg/m² BSA day 29
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital Tuebingen, Tuebingen, Baden-Wuerttemberg, Germany
University Hospital Ulm, Ulm, Baden-Wuerttemberg, Germany
Hannover Medical School, Hannover, Niedersachsen, Germany
University Hospital of Heidelberg, Heidelberg, , Germany
University of Leipzig Medical Center, Leipzig, , Germany
Contact Details
Name: Helmut Salih, Prof. Dr.
Affiliation: Department of Internal Medicine, Internal Medicine II; Oncology, haematology, clinical immunology, rheumatology and pneumology University Hospital Tuebingen
Role: PRINCIPAL_INVESTIGATOR
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