Sorafenib In Relapse of FMS-like Tyrosine Kinase 3 (FLT3)-Internal Tandem Duplication (ITD) AML Trial
NCT ID: NCT02867891
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
396 participants
OBSERVATIONAL
2001-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chemotherapy alone
The specific interventions to the subjects of the study are assigned by the individual transplant center
No interventions assigned to this group
Chemotherapy/DLI
The specific interventions to the subjects of the study are assigned by the individual transplant center
No interventions assigned to this group
Sorafenib alone
The specific interventions to the subjects of the study are assigned by the individual transplant center
No interventions assigned to this group
Sorafenib/DLI
The specific interventions to the subjects of the study are assigned by the individual transplant center
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Treatment with either chemotherapy-alone, chemotherapy/DLI, sorafenib alone or sorafenib/DLI
* Written informed consent
* Ability to understand the nature of the study and the study related procedures and to comply with them
Exclusion Criteria
* Lack of informed consent
* Patients that cannot be classified in one of the 4 groups: chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group
18 Years
ALL
No
Sponsors
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Robert Zeiser
OTHER
Responsible Party
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Robert Zeiser
Head of Tumor Imunnology and Immun regulation
Principal Investigators
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Robert Zeiser, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical Center University of Freiburg
References
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Metzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Gotze K, Linn YC, Kroger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Muller L, Giagounidis A, Meyer RG, Brugger W, Vohringer M, Dreger P, Mori M, Basara N, Schafer-Eckart K, Schultheis B, Baldus C, Neubauer A, Burchert A. High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses. Leukemia. 2012 Nov;26(11):2353-9. doi: 10.1038/leu.2012.105. Epub 2012 Apr 16.
De Freitas T, Marktel S, Piemontese S, Carrabba MG, Tresoldi C, Messina C, Lupo Stanghellini MT, Assanelli A, Corti C, Bernardi M, Peccatori J, Vago L, Ciceri F. High rate of hematological responses to sorafenib in FLT3-ITD acute myeloid leukemia relapsed after allogeneic hematopoietic stem cell transplantation. Eur J Haematol. 2016 Jun;96(6):629-36. doi: 10.1111/ejh.12647. Epub 2015 Sep 21.
Other Identifiers
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SIRA
Identifier Type: -
Identifier Source: org_study_id
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