Acute Myeloid Leukemia Clinical Trial
— SIRAOfficial title:
Multicenter, Observational Trial to Determine the Response Rate of Sorafenib and Donor Lymphocyte Infusions (DLI) Versus Best Available Treatment (BAT) in FLT3-ITD-mutant AML Relapse After Allogeneic Hematopoietic Cell Transplantation
Verified date | January 2017 |
Source | University of Freiburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this trial the investigators will evaluate the outcomes of 4 pre‐defined groups of individuals according to the therapeutic intervention. The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse after allo-HSCT.
Status | Completed |
Enrollment | 396 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histology/PCR proven relapse of FLT3-ITD+ AML after allo-HSCT - 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: - Age < 18 years - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Robert Zeiser |
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. — View Citation
Metzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Götze K, Linn YC, Kröger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Müller L, Giagounidis A, Meyer RG, Brugger W, Vöhringer M, Dreger P, Mori M, Basara N, Schäfer-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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to treatment | The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission. | 10 years | |
Secondary | Overall survival (OS) of the participants | 10 years | ||
Secondary | Serum cytokine levels (Interleukin (IL)-15, Interferon-gamma, IL-6) of the participants. | 10 years | ||
Secondary | Number of participants with acute graft-versus-host disease (GvHD). | 10 years |
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