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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.
The preliminary data of the investigators demonstrate potent activity of Sorafenib combined with Donor lymphocyte infusions (DLI) in relapse of FLT3-ITD+ Acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HSCT). The investigators therefore launched an observational multicenter trial. The outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention (chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group). The specific interventions to the subjects of the study are assigned by the individual transplant center. The investigators will determine the outcome of each group by monitoring the survival and the response rates (complete remission, disease burden reduction, no response) of patients with FLT3-ITD AML relapse after allo-HSCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy alone | The specific interventions to the subjects of the study are assigned by the individual transplant center | ||
| Chemotherapy/DLI | The specific interventions to the subjects of the study are assigned by the individual transplant center | ||
| Sorafenib alone | The specific interventions to the subjects of the study are assigned by the individual transplant center | ||
| Sorafenib/DLI | The specific interventions to the subjects of the study are assigned by the individual transplant center |
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| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment | The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) of the participants | 10 years | |
| Serum cytokine levels (Interleukin (IL)-15, Interferon-gamma, IL-6) of the participants. | 10 years | |
| Number of participants with acute graft-versus-host disease (GvHD). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapse of FLT3-ITD AML after allogeneic hematopoietic stem cell transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Robert Zeiser, Prof. Dr. | Medical Center University of Freiburg | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22504140 | Background | 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. | |
| 26260140 |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Serum cytokine levels (IL-15, IFN-gamma, IL-6)
| 10 years |
| Background |
| 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |