NCT02867891

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2001

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
15.5 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

15.8 years

First QC Date

August 10, 2016

Last Update Submit

January 16, 2017

Conditions

Acute Myeloid Leukemia

Keywords

FLT3-ITDAMLallo-HSCT

Outcome Measures

Primary Outcomes (1)

  • Response to treatment

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

    10 years

Secondary Outcomes (3)

  • 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

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with relapse of FLT3-ITD AML after allogeneic hematopoietic stem cell transplantation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Metzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Gotze K, Linn YC, Kroger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Muller L, Giagounidis A, Meyer RG, Brugger W, Vohringer M, Dreger P, Mori M, Basara N, Schafer-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. Epub 2012 Apr 16.

    PMID: 22504140BACKGROUND

  • 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. Epub 2015 Sep 21.

    PMID: 26260140BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum cytokine levels (IL-15, IFN-gamma, IL-6)

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Robert Zeiser, Prof. Dr.

    Medical Center University of Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Tumor Imunnology and Immun regulation

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 16, 2016

Study Start

March 1, 2001

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share