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.
Study Type
OBSERVATIONAL
Enrollment
396
Response to treatment
The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission.
Time frame: 10 years
Overall survival (OS) of the participants
Time frame: 10 years
Serum cytokine levels (Interleukin (IL)-15, Interferon-gamma, IL-6) of the participants.
Time frame: 10 years
Number of participants with acute graft-versus-host disease (GvHD).
Time frame: 10 years
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