NCT02757989Completed
Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome Low Risk
Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Low or Intermediate-1 Myelodysplastic Syndrome: A Prospective Multicenter Phase II Study Based on Donor Availability on Behalf of the GFM & SFGM-TC
Source: ClinicalTrials.gov · Last updated 2 Aug 2024
Brief summary (registry, in English)
Comparison of survival in patients with or without a matched donor at 36 months
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 31 Mar 2016
- Start date
- 31 May 2016
- Primary completion date
- 7 Jun 2024
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT02757989
What you commit to
- Study type: Interventional
- Participants enrolled: 79
- From 31 May 2016 to the primary completion date, 7 Jun 2024
- 37 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe active infection or any other uncontrolled severe condition.
- Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
- MDS with the following causal germline disease : Fanconi anemia, GATA2 related syndromes and telomere disorders
Lab values
- Organ dysfunctions including the following
- Hepatic : total bilirubin \> 2 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) \> 3xULN
- Symptomatic respiratory chronic failure
- Symptomatic cardiac failure
- Renal clearance \< 60ml/min
Other
- MDS classified according to classical IPSS as intermediate 2 or High risk
- Transformation in Acute myeloid Leukemia (AML)
Who the study is looking for
- Signed Informed consent
- Classical IPSS intermediate 1 or low myelodysplastic syndrome associated with at least one poor prognosis feature:
- Intermediate or higher risk revised IPSS
- RBC transfusion dependent anemia and failure to 2 or more lines or therapy (including EPO, Lenalidomide or demethylating agent…)
- thrombocytopenia \< 20 G/L requiring transfusion
- neutropenia \< 0.5 G/L associated with severe infection (defined as requiring hospitalization)
- Patient aged ≥ 18 and \< 70 years For young patients, 18-45 years, Fanconi disease and dyskeratosis should be ruled out
- Patient for whom a transplantation from a matched donor, (8/8 (HLA A, B, C, DRB1) identical at molecular level)unrelated donor or matched sibling), is considered irrespective of donor availability
- Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (At time of screening)
- Negative pregnancy and adequate contraception (including in male patients wishing to father), if relevant.
- Wash-out of at least 30 days since a previous treatment with Vidaza, Lenalidomide, EPO or any other treatment inducing cytopenias.
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU D'amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil | France | Unknown status |
| Chu Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Hopital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| CHU de Haut Lévèque Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHRU Côte de Nacre Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHSF Gilles de Corbeil Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Unknown status |
| Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CH Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| Hopital Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hopital Saint Vincent de Paul Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hopital Dupuytren Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Centre Hospitalier Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| GHEF Site de Meaux Coordinator of this site? Confirm its status | Meaux | France | Unknown status |
| CHRU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Necker Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CH Joffre Coordinator of this site? Confirm its status | Perpignan | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CH René Dubos Coordinator of this site? Confirm its status | Pontoise | France | Unknown status |
| CHU de Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Hôpital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Institut Curie Coordinator of this site? Confirm its status | Saint-Cloud | France | Unknown status |
| Institut de Cancérologie Lucien Neuwirth Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Hopital Civil Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| IUCT Oncopôle Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Hôpital de Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.