Sorafenib In Relapse of FMS-like Tyrosine Kinase 3 (FLT3)-Internal Tandem Duplication (ITD) AML Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy alone<br>The specific interventions to the subjects of the study are assigned by the individual transplant center | |
| Chemotherapy/DLI<br>The specific interventions to the subjects of the study are assigned by the individual transplant center | |
| Sorafenib alone<br>The specific interventions to the subjects of the study are assigned by the individual transplant center | |
| Sorafenib/DLI<br>The specific interventions to the subjects of the study are assigned by the individual transplant center | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FLT3-ITD, AML, allo-HSCT