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

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ClinicalTrials.gov Identifier: NCT02867891
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Zeiser, University of Freiburg

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.

Condition or disease
Acute Myeloid Leukemia

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.

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Study Type : Observational
Actual Enrollment : 396 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2001
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Group/Cohort
Chemotherapy alone
The specific interventions to the subjects of the study are assigned by the individual transplant center
Chemotherapy/DLI
The specific interventions to the subjects of the study are assigned by the individual transplant center
Sorafenib alone
The specific interventions to the subjects of the study are assigned by the individual transplant center
Sorafenib/DLI
The specific interventions to the subjects of the study are assigned by the individual transplant center



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Serum cytokine levels (IL-15, IFN-gamma, IL-6)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with relapse of FLT3-ITD AML after allogeneic hematopoietic stem cell transplantation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867891


Sponsors and Collaborators
Robert Zeiser
Investigators
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Principal Investigator: Robert Zeiser, Prof. Dr. Medical Center University of Freiburg

Publications:
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Responsible Party: Robert Zeiser, Head of Tumor Imunnology and Immun regulation, University of Freiburg
ClinicalTrials.gov Identifier: NCT02867891     History of Changes
Other Study ID Numbers: SIRA
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Robert Zeiser, University of Freiburg:
FLT3-ITD
AML
allo-HSCT

Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action