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New treatment option for Acute Leukemia in Remission
Official title Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT04935684
What this study is testing
What is Fecal Microbiota Transplantation?
Fecal Microbiota Transplantation is an investigational medicine, being studied as a potential treatment for acute leukemia in remission.
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
- The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD). The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient aged 18 or over
- Men and women
- Patients affiliated with a social-security organization
- Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of...
- Signed and dated informed consent
You likely can't join if
- Status of tumor progression at the time of allo-HSCT
- Inability to understand the protocol (linguistic barrier, cognitive difficulties)
- Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)
- Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)
- Fecal incontinence
- Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a...
See the full eligibility criteria
- Patient aged 18 or over
- Men and women
- Patients affiliated with a social-security organization
- Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood)
- Signed and dated informed consent
- Status of tumor progression at the time of allo-HSCT
- Inability to understand the protocol (linguistic barrier, cognitive difficulties)
- Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)
- Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)
- Fecal incontinence
- Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the how well it works of a...
- Pregnant women
- Patient under guardianship, curatorship or protection of justice
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Besançon, France
- Clermont-Ferrand, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Pessac, France
- Poitiers, France
- Rouen, France
- Saint-Etienne, France
- Toulouse, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Besançon, France; Clermont-Ferrand, France; Grenoble, France; Lille, France and 11 more location(s). 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.