Skip to main content
OpenTrials
Completed

NCT Number: NCT02867891

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response to treatment

    Time frame: 10 years

    The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission.

Secondary outcomes

  1. Overall survival (OS) of the participants

    Time frame: 10 years

  2. Serum cytokine levels (Interleukin (IL)-15, Interferon-gamma, IL-6) of the participants.

    Time frame: 10 years

  3. Number of participants with acute graft-versus-host disease (GvHD).

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Robert Zeiser

Other

Registry information

Official study title

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

Acronym: SIRA

Important dates

Study start
2001
Primary completion
2016
Study completion
2016
First posted
Aug 16, 2016
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.