A Phase 2 interventional study of Fecal Microbiota Transplantation in Acute Leukemia in Remission, Myelodysplastic Syndromes and Myeloproliferative Syndrome, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment
Among 198 studies in Myelodysplastic Syndromes with a site in France — 36 open to participants now, 54 under way, 13 of them phase 3. Myelodysplastic Syndromes · France.
Among the 198 studies in Myelodysplastic Syndromes with a site in France, this one is the 58th largest by planned enrollment of the 172 interventional ones, is one of 12 that started in 2022, is one of 53 in phase 2, reaches primary completion later than 50 of the 53 other live ones, and was the 157th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →36 of the 198 studies in Myelodysplastic Syndromes with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 262 Myelodysplastic Syndromes studies recruiting now, 165 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →198 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 12 started in 2022.
Median enrollment 93 across the 172 interventional studies, 137 across the 25 observational. Of the 117 that completed or were terminated, 46 (39%) have results posted.
97 of 198 have an industry lead sponsor. The 10 most frequent:
University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
University Hospital, Clermont-Ferrand has 2 studies filed under Myelodysplastic Syndromes — fewer than ten, so there is no comparison to draw.
14 of the studies in Myelodysplastic Syndromes with a site in France that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04401748Phase 3AbbVieStudy Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome | 2027-07 |
| NCT04256317Phase 3Taiho Oncology, Inc.A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | 2027-11-01 |
| NCT06465953Phase 3Institut de Recherches Internationales ServierIvosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation | 2027-11-01 |
| NCT06987058Ryvu Therapeutics SARVU120 Rollover Study | 2026-12 |
| NCT06782373Swedish Orphan BiovitrumA Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS) | 2026-12-30 |
Among the 198 studies in Myelodysplastic Syndromes with a site in France, from their registry updates:
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.
The TMF-Allo study is a prospective, open-label, multi-center, parallel, randomized phase II clinical trial comparing a group patients with FMT and a control group of patients without FMT.
The main objective of this study is to assess the effect of allogeneic FMT versus no treatment on Graft-versus-host disease and Relapse-Free Survival (GRFS) at one year in adult patients treating with myelo-ablative allo-HSCT for haematologic malignancy.
The secondary objectives are to evaluate :
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized in the "FMT group" will received FMT. FMT product will be made by the the pharmacy of the Clermont-Ferrand University Hospital from stools of healthy volunteer donors within 6 hours after defecation in order to preserve the viability of the bacteria. The preparation will be standardized: 50g aliquots will be prepared and diluted in 250mL of 0.9% NaCl containing 10% glycerol, until a homogeneous suspension is obtained. The preparation will be rapidly frozen at -80°C until use, with a maximum shelf life of 18 months.
Drug: Fecal Microbiota Transplantation
The comparator group will be constituted by patients randomized in the "no FMT" group. For ethical reasons, these patients will not receive any FMT and therefore no enema or colic preparation. No placebo will be administered. Prophylactic anti-infective treatments can be introduced at any time.
Patients randomized in the "FMT group" will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT. The enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes.
Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation
GRFS is a composite endpoint of GvHD-free/relapse-free survival in which events include grade II-IV acute GvHD, moderate and severe chronic GvHD, relapse, or death in the first year post-HSCT. GRFS will be measured at one year after allo-HSCT and compared between both groups of patients.
Time frame: at Day 360 after allogeneic hematopoietic stem cell transplantation
Overall survival
Overall survival is defined as the time period between the date of randomization and the date of death, regardless of its cause.
Time frame: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Progression-free survival
Progression-free survival is defined as the time period between the date of randomization and the date of disease relapse or progression or death, regardless of its cause.
Time frame: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Haematopoietic reconstitution
Haematopoietic reconstitution is assessed by: 1/ turnaround time of polynuclear neutrophils \>0.5.10\^9/L (first day within a period of three consecutive days); 2/ spontaneous platelet turnaround time \>20.10\^9/L (two days with no platelet transfusion within the previous three days); 3/ spontaneous platelet turnaround time \>50.10\^9/L (two days with no platelet transfusion within the previous three days); 4/ the number of transfusions of red blood cells and platelets between D0 and D100
Time frame: At the time of haematopoietic reconstitution
Engraftment rates
Engraftment rates are evaluated by a chimerism measure (by molecular biology)
Time frame: At Day 30, Day 60, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantationday
Cumulative incidence of acute GvHD
Acute GvHD severity is defined according to MAGIC criteria. It will be notified by specifying the location (liver, skin, gut …), the severity score (II to IV), the treatment applied and the efficacy of treatment. GvHD occurrence will be notified every week until D30 (minimum) or until hospital discharge, then monthly until D180 and at D270, D360, D540 and D720.
Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation
Cumulative incidence of chronic GvHD
Chronic GvHD severity will be defined according to NIHCC criteria. It will be notified by specifying the location (liver, skin, gut …), the severity score (II to IV), the treatment applied and the efficacy of treatment. GvHD occurrence will be notified every week until ungraftment, then monthly until D180 and at D270, D360, D540 and D720.
Time frame: At Day 720 after allogeneic hematopoietic stem cell transplantation
Transplant-Related Mortality
Transplant-related mortality is defined as death due to causes unrelated to the underlying disease.
Time frame: At Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Cumulative incidence of infections
Infectious complications will be notified every week up to day 30 (minimum) or until hospital discharge, then every month up to D180 and from D270 to D360, according to the existence of a documented bacteraemia, germ resistance, type and number of days of curative antibiotherapy used; the existence of a documented fungal infection and the type and number of days of curative antifungal treatment; the existence of a documented viral infection and the type and number of days of curative antiviral treatment; the need of an intensive care unit transfer due to an infectious complication.
Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation
Severe infections description
Severe infections will be defined according to GREFIG score : bactearemia with severe sepsis, complex bactearemia (with deep organ involvement), candidemia (at least one positive blood culture) with sepsis or deep infected site, proven or probable aspergillosis pneumonia, severe varicella-zoster virus infection (involvement of a deep organ or associated coagulopathy), any viral encephalitis, CMV infection with lung or digestive location, Pneumocystis jiroveci pneumonia, toxoplasmosis with involvement of organ or central nervous system, any acute pneumonia with PaO2 less than or equal to 65mmHg, any sepsis requiring transfer to an intensive care unit.
Time frame: From the day of inclusion to Day 360 after allogeneic hematopoietic stem cell transplantation
Impact of Fecal Microbiota Transplantation (FMT) on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection
Impact of FMT on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection will be assessed by evaluation of persistence or disappearance of these pathogenic bacteria after FMT.
Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation
Unexpected event description that could be in relation with FMT of Fecal Microbiota Transplantation (FMT)
Each unexpected event that could be in relation with FMT will be notified: abdominal pain, diarrhea, bacterial translocation or any adverse effect attributed to the enema.
Time frame: From the day of FMT to Day 360 after allogeneic hematopoietic stem cell transplantation
Quality of life assessment
The quality of life will be auto-evaluated by the patients using a validated questionnaire: European Organisation for Research and Treatment of Cancer- Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: at Day -7, Day 30, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Analysis the intestinal microbiota in patients
The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all patients with FMT and without FMT.
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Analysis the intestinal microbiota in stool donnors
The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all stool donnors.
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Blood collection for a metabolomic study in patients
A blood collection will be set up from blood samples collected on patients from both groups. These samples will be used for a metabolomic study (tryptophan, indoleamine 2,3-dioxygenase, short chain fatty acid, bile acids).
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Blood collection for an analysis of anti-microbiota IgG and IgA in patients
A blood collection will be set up from blood samples collected on patients from both groups. These samples will be used for an analysis of anti-microbiota IgG and IgA.
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Blood collection for a metabolomic study in stool donnors
A blood collection will be set up from blood samples collected on stool donnors. These samples will be used for a metabolomic study (tryptophan, indoleamine 2,3-dioxygenase, short chain fatty acid, bile acids).
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Blood collection for an analysis of anti-microbiota IgG and IgA in stool donnors
A blood collection will be set up from blood samples collected on stool donnors. These samples will be used for an analysis of anti-microbiota IgG and IgA.
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Stool collection for an analysis of the virome in patients
A stool collection will be carried out from stool samples collected on patients from both groups.These samples will be used for an analysis of the virome evolution.
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Stool collection for an analysis of the virome in stool donnors
A stool collection will be carried out from stool samples collected on stool donnors.These samples will be used for an analysis of the virome evolution.
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Plan to share: Yes — Full protocol, participant-level data, statistical codes, trial datasets and analyses will be made available on request from the corresponding author after examining the request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: At the end of the study, on request from the corresponding author after examining the request.
Access criteria: On request from the corresponding author after examining the request.
Started Dec 2022 (actual). Primary completion is estimated for May 2030, 89 months after the start.
Of 227 non-industry phase 2 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 116. This study's planned 89 months is above that.
Counting every sponsor, half of 279 studies reached it within 66 months; a quarter within 40 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
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University Hospital, Clermont-Ferrand →