Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome Low Risk
NCT ID: NCT02757989
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2016-05-31
2024-06-07
Brief Summary
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Detailed Description
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Patients without a matched donor received the best available treatment. All patients will be followed at least 36 months or until the end of the study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with donor
Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling)
transplantation
allogeneic hematopoietic stem cell transplantation in patients with donor
Patients without donor
Patients without a matched donor
No interventions assigned to this group
Interventions
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transplantation
allogeneic hematopoietic stem cell transplantation in patients with donor
Eligibility Criteria
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Inclusion Criteria
2. Classical IPSS intermediate 1 or low myelodysplastic syndrome associated with at least one poor prognosis feature:
1. Intermediate or higher risk revised IPSS
2. RBC transfusion dependent anemia and failure to 2 or more lines or therapy (including EPO, Lenalidomide or demethylating agent…)
3. thrombocytopenia \< 20 G/L requiring transfusion
4. neutropenia \< 0.5 G/L associated with severe infection (defined as requiring hospitalization)
3. Patient aged ≥ 18 and \< 70 years For young patients, 18-45 years, Fanconi disease and dyskeratosis should be ruled out
4. 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
5. Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (At time of screening)
6. Negative pregnancy and adequate contraception (including in male patients wishing to father), if relevant.
7. Wash-out of at least 30 days since a previous treatment with Vidaza, Lenalidomide, EPO or any other treatment inducing cytopenias.
Exclusion Criteria
2. Transformation in Acute myeloid Leukemia (AML)
3. Severe active infection or any other uncontrolled severe condition.
4. 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
5. Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
6. MDS with the following causal germline disease : Fanconi anemia, GATA2 related syndromes and telomere disorders
18 Years
69 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Neovii Biotech
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
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Principal Investigators
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Marie Robin, MD
Role: PRINCIPAL_INVESTIGATOR
Saint-Louis Hospital, Paris, France
Locations
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CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
Centre hospitalier Victor Dupouy
Argenteuil, , France
CHU Jean Minjoz
Besançon, , France
Hôpital Avicenne
Bobigny, , France
CHU de Haut Lévèque
Bordeaux, , France
CHRU Côte de Nacre
Caen, , France
CHU Estaing
Clermont-Ferrand, , France
CHSF Gilles de Corbeil
Corbeil-Essonnes, , France
Hôpital Henri Mondor
Créteil, , France
CHU de Grenoble
Grenoble, , France
CH Le Mans
Le Mans, , France
Hôpital Saint Vincent de Paul
Lille, , France
Hôpital Huriez
Lille, , France
Hôpital Dupuytren
Limoges, , France
Centre hospitalier Lyon Sud
Lyon, , France
GHEF, site de Meaux
Meaux, , France
CHRU de Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
CHU de Nice
Nice, , France
CHU de Nîmes
Nîmes, , France
Hôpital Saint Louis
Paris, , France
Hôpital Pitié Salpétrière
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Necker
Paris, , France
CH Joffre
Perpignan, , France
CHU de Poitiers
Poitiers, , France
CH René Dubos
Pontoise, , France
CHU de Reims
Reims, , France
Hôpital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut Curie
Saint-Cloud, , France
Institut de cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Hôpital civil
Strasbourg, , France
IUCT-Oncopole
Toulouse, , France
Hôpital Bretonneau
Tours, , France
Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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Robin M, Fenaux P. Which lower risk myelodysplastic syndromes should be treated with allogeneic hematopoietic stem cell transplantation? Leukemia. 2020 Oct;34(10):2552-2560. doi: 10.1038/s41375-020-0967-x. Epub 2020 Jul 13.
Other Identifiers
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2015-A00292-47
Identifier Type: OTHER
Identifier Source: secondary_id
MDS-ALLO-RISK
Identifier Type: -
Identifier Source: org_study_id
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