BridgeMD
New treatment option for Transplantation, Hematopoietic Stem Cell
Official title Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients
ClinicalTrials.gov ID: NCT05947864
What this study is testing
What is Biological samples (blood and oral fluid)?
Biological samples (blood and oral fluid) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for transplantation, hematopoietic stem cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Measles, a highly contagious disease, is potentially serious in adult allogenic hematopoietic stem cell transplant (allo-HSCT) recipients. Because of the loss of immunity to vaccine preventable diseases after allo-HSCT, French Health Authorities (Haut Conseil de Santé Publique, HCSP) recommend (re)vaccination of all allo-HSCT recipients against measles-mumps-rubella (MMR) from 24 months post-transplant onwards, in the absence of graft-versus-host disease (GVHD) and at least 3 months after cessation of all immunosuppressive treatments, irrespective of measles serostatus.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Study population:
- Aged ≥ 18 years and ≤ 75 years,
- Have received an allo-HSCT ≥ 24 months ago,
- In complete remission of initial hematologic disease and with successful engraftment (recipient chimerism \<0.3% on whole blood),
- Without extensive chronic GVHD,
You likely can't join if
- Study population:
- History of autoimmune disease or acquired immunodeficiency (other than the hematological disease),
- Patients undergoing pharmacological immunosuppression or biotherapy or extracorporeal photopheresis at the time of inclusion, or whose...
- Patients having received ≥ 1 infusion of IVIG in the 8 months prior to inclusion,
- Patients whose last HSCT was an autograft,
- Patients with known chronic active infection with human immunodeficiency virus (HIV) and/or hepatitis B or C virus(es),
See the full eligibility criteria
- Study population:
- Aged ≥ 18 years and ≤ 75 years,
- Have received an allo-HSCT ≥ 24 months ago,
- In complete remission of initial hematologic disease and with successful engraftment (recipient chimerism \<0.3% on whole blood),
- Without extensive chronic GVHD,
- Having given their written consent,
- Affiliated to a social security plan,
- Able to attend all scheduled visits and to comply with all study procedures. Healthy volunteers:
- Aged ≥ 18 years and ≤ 75 years,
- Having a history of measles (=convalescent) or have been vaccinated in the past with two doses of MMR (=vaccinated),
- Having given their written consent,
- Affiliated to a social security plan.
- Study population:
- History of autoimmune disease or acquired immunodeficiency (other than the hematological disease),
- Patients undergoing pharmacological immunosuppression or biotherapy or extracorporeal photopheresis at the time of inclusion, or whose immunosuppressive treatment (corticosteroids and anti-rejection agents) has been...
- Patients having received ≥ 1 infusion of IVIG in the 8 months prior to inclusion,
- Patients whose last HSCT was an autograft,
- Patients with known chronic active infection with human immunodeficiency virus (HIV) and/or hepatitis B or C virus(es),
- Patients deprived of liberty by judicial or administrative decision,
- Patients under legal protection or unable to consent to the study,
- Patients participating in another treatment research study with an exclusion period still in progress at pre-inclusion,
- Pregnant, parturient or breast-feeding women. Healthy volunteers:
- History of autoimmune disease or acquired immunodeficiency,
- History of pharmacological immunosuppression or biotherapy discontinued less than 3 months ago (12 months for anti-CD20 including rituximab),
- History of IVIG infusion in the 8 months prior to inclusion,
- Persons deprived of liberty by judicial or administrative decision.
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.