Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease

Hemopathy Clinical Trial

— Predictor007  

Official title:

Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02751112
• Other study ID #: IMIS2014-03
• Status: Terminated
• Phase: N/A
• First received: April 13, 2016
• Last updated: October 30, 2017
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Imagine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a proof of concept that will assess the Predictor's kit performances. The test will be performed by several technicians, in immunological laboratories of several sites in France.

In this study, "couples" of donor / recipient in the frame of a graft of CSH will be included.

Description:

The Hematopoietic Stem Cell (HSC) graft is the only curative treatment for lots of hematologic diseases, malignant or not, particularly leukemias.

The acute Graft versus Host (aGvH) reaction is the most frequent complication, and could concern until 50% of recipients. It is mainly linked to immune characteristics of the donor which will act versus the graft recipient.

There is a huge need of a technology that could predict the risk of aGvH, especially in order to select a donor in case of several possibilities, in order to reduce morbidity and mortality of graft.

The Predictor' kit allows to predict acute and severe forms of Graft versus Host disease before the graft of peripheral hematological stem cells, by the assesment of iNKT cells expansion.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Main inclusion Criteria for Donors :

• Being a relative of the recipient patient, OR being registered on the National Registry of the volunteers for bone marrow donation

• Being candidate for a donation of Hematologic Stem Cells with a HLA compatibility 10/10

Main inclusion Criteria for Recipient :

• Being candidate for a donation of Hematologic Stem Cells with the following criteria:

• HLA compatibility 10/10 with the donor

• Suffering from malignant or non-malignant hemopathy in first remission

• Myeloablative or reducted intensity conditioning

• Classic scheme of immunosuppression decreasing

Main exclusion Criteria:

• Participation to a therapeutical protocol in the 30 last days

Related Conditions & MeSH terms

• Graft vs Host Disease
• Hemopathy

Intervention

Biological:
• Predictor' kit
Realization of the Predictor' kit on the blood of donor of HSC, in the frame of a graft, to predict a aGvH reaction on recipient patient.

Locations

Country	Name	City	State
France	Centre Hospitalier de Caen	Caen
France	Hôpital de Huriez / CHRU de Lille	Lille
France	Hôpital Necker Enfants Malades	Paris
France	Hôpital Haut-Lévèque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the diagnosis test performance	The performance of the test will be assessed via the observation of the number of aGvH 6 months after the graft, reported to the the expansion of iNKT cells.; Assessment of sensitivity and specificity of the diagnosis test	6 months
Secondary	Assessment of the reproductibility of the test	The reproductibility of the test will be assessed by comparing the results obtained by 2 distinct operators : the immunology lab technician, and the referent operator at Imagine Institute research lab.; The 2 operators will perform the test in parallel on the blood of the same donor, in similar conditions, and both by using a Predictor's kit.	6 months