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

Acute Myeloid Leukemia Clinical Trial

— SIRA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867891
• Other study ID #: SIRA
• Status: Completed
• Phase: N/A
• First received: August 10, 2016
• Last updated: January 16, 2017
• Start date: March 2001
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Robert Zeiser

References & Publications (2)

De Freitas T, Marktel S, Piemontese S, Carrabba MG, Tresoldi C, Messina C, Lupo Stanghellini MT, Assanelli A, Corti C, Bernardi M, Peccatori J, Vago L, Ciceri F. High rate of hematological responses to sorafenib in FLT3-ITD acute myeloid leukemia relapsed after allogeneic hematopoietic stem cell transplantation. Eur J Haematol. 2016 Jun;96(6):629-36. doi: 10.1111/ejh.12647. — View Citation

Metzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Götze K, Linn YC, Kröger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Müller L, Giagounidis A, Meyer RG, Brugger W, Vöhringer M, Dreger P, Mori M, Basara N, Schäfer-Eckart K, Schultheis B, Baldus C, Neubauer A, Burchert A. High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses. Leukemia. 2012 Nov;26(11):2353-9. doi: 10.1038/leu.2012.105. — View Citation

Outcome

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