- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01520623
Complement and Graft-versus-host Disease
Role of Complement System in Human Allogeneic Haematopoietic Stem Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be performed in allografted patients with myeloablative conditioning for an haematological malignancy from 3 adult transplant units.
Patients will be followed for at least12 months after transplantation and blood samples drawn before conditioning and once a week for 12 weeks after transplantation to analyze:
- serum concentration of Complement factors (C3, C4, B factor), Complement regulatory proteins (C1-inhibitor, I and H Factors) and analysis of the surface expression of Complement regulatory molecules such as CD46, CD55 and CD59.
- serum inflammatory cytokine levels
In addition, patients with clinical signs of gut GVHD will be explored by gastrointestinal endoscopy to perform gut biopsies. C5b9 deposure will be then analyzed by immunohistochemistry on GVHD lesions.
Activation of complement system will be defined by a decrease of complement factor levels of 50% and values under lower physiological limits. The clinical evolution and the inflammatory cytokine profile of patients with such an activation profile will be compared to that of those without complement activation.
A data base containing biological and clinical data will be established. Biological results will be correlated to post-transplant clinical events, in particular the occurrence of gut GVHD but also non relapse mortality and overall survival by adapted statistical tests (comparison of percentages by Chi-2 of Pearson, comparison of survival curves by logrank, multivariate analysis by logistic regression test or cox model).
The number of required patients will be established by comparison of the percentage of gut GVHD in the patients with or without complement activation. Based on our preliminary results, we hypothesize that 2/3 patients will not have complement activation among whose 20% will develop acute gut GVHD. We expect an increase of acute gut GVHD up to 60% of the patients with complement activation that would represent 1/3 of the cohort.
With a bilateral alpha risk of 5% and a power of 80%, the number of required patients is 23 in the activated group and 46 in the non activated group, thus a total of 69 patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75010
- Saint Louis hospital
-
Paris, France, 75012
- Saint Antoine Hospital
-
Paris, France, 75
- Necker Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Allografted patients with myeloablative conditioning for an haematological malignancy
- Age > 18 years old and < 65 years.
- The patient must have access to social insurance according to local regulations.
- Patient must give a written informed consent (personally signed and dated) before completing any study related procedure
Exclusion Criteria:
- Age < 18 years old and > 65 years
- Patient with active infection HIV, HTLV1, Hepatite B ou C
- Uncontrolled infection(s), (i.e. documented bacterial, parasitical, or fungal infection).
- Patient with lupus
- Patient with transaminases > 5N, TP<30% with Facteur V < 30% before allogreffe
- Creatinine clearance < 50ml/min
- Absence of any psychological condition potentially hampering signing informed consent
- Patient refused to sign informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Allografted patients
Allografted patients with myeloablative conditioning for an haematological malignancy.
Patients will be followed for at least 12 months after transplantation and blood samples drawn before conditioning and once a week for 12 weeks after transplantation to analyze the serum concentration of Complement factors (C3, C4, B factor), Complement regulatory proteins (C1-inhibitor, I and H Factors) and analysis of the surface expression of Complement regulatory molecules such as CD46, CD55 and CD59 and the serum inflammatory cytokine levels
|
Allografted patients with myeloablative conditioning for an haematological malignancy.
Patients will be followed for at least 12 months after transplantation and blood samples drawn before conditioning and once a week for 12 weeks after transplantation to analyze the serum concentration of Complement factors (C3, C4, B factor), Complement regulatory proteins (C1-inhibitor, I and H Factors) and analysis of the surface expression of Complement regulatory molecules such as CD46, CD55 and CD59 and the serum inflammatory cytokine levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activation of the complement system and the development of acute gut GvHD
Time Frame: 12 weeks
|
Assessment of the activation of the complement system after human allogeneic stem cell transplantation and of its potential correlation with the development of acute gut GvHD
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 2 years
|
Overall Survival at 3, 6, 9 , 12 and 24-month Post HCST
|
2 years
|
Overall survival without relapse
Time Frame: 2 Years
|
Relapse
|
2 Years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marie-Thérèse RUBIO, MD, PhD, Saint Antoine Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC 08025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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