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

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT02867891
• Lead Sponsor: Robert Zeiser

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.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-13
• Study First Posted: 2016-08-16
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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