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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02867891

Acronym

SIRA

Enrollment

396

Registered

2016-08-16

Start date

2001-03-31

Completion date

2016-12-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

FLT3-ITD, AML, allo-HSCT

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Response to treatment	10 years	The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission.

Secondary

Measure	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

Outcome results