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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 (NCT02757989)

Novartis
Neovii Biotech
Comparison of survival in patients with or without a matched donor at 36 months
  • Other: transplantation
    allogeneic hematopoietic stem cell transplantation in patients with donor
    Ages eligible for Study
    45 Years to 69 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Signed Informed consent
    • All patients should have the following disease criteria together
    • MDS classified according to classical IPSS as intermediate 1 or low
    • MDS classified according to revised IPSS at least intermediate
    • Patients who failed to an approved treatment which can be EPO, lenalidomide or Vidaza® or who are not eligible for such a treatment or who have thrombocytopenia < 20 G/L requiring transfusion or neutropenia < 0.5 G/L associated with severe infection (defined as requiring hospitalization)
    • Age ≥ 45 and < 70 years
    • 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.
    Exclusion Criteria:
    • MDS classified according to classical IPSS as intermediate 2 or High risk
    • Transformation in Acute myeloid Leukemia (AML)
    • Severe active infection or any other uncontrolled severe condition.
    • 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
    • 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
    Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling) received an allogeneic hematopoietic stem cell transplantation.

    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.

    28 locations

    France (28)
    • CHU d'Amiens
      not yet recruiting
      Amiens, France, 80054
    • CHU d'Angers
      recruiting
      Angers, France, 49933
    • CHU Jean Minjoz
      recruiting
      Besançon, France, 25030
    • Hôpital Avicenne
      not yet recruiting
      Bobigny, France, 93009
    • CHU de Haut Lévèque
      recruiting
      Bordeaux, France, 33604
    • CHRU Côte de Nacre
      not yet recruiting
      Caen, France, 14033
    • CHU Estaing
      recruiting
      Clermont Ferrand, France, 63000
    • CHU de Grenoble
      recruiting
      Grenoble, France, 38043
    • CH Le Mans
      not yet recruiting
      Le Mans, France, 72037
    • Hôpital Saint Vincent de Paul
      recruiting
      Lille, France, 59020
    • Hôpital Huriez
      recruiting
      Lille, France, 59037
    • Hôpital Dupuytren
      not yet recruiting
      Limoges, France, 87042
    • Centre hospitalier Lyon Sud
      not yet recruiting
      Lyon, France, 69495
    • CHRU de Montpellier
      not yet recruiting
      Montpellier, France, 34295
    • CHU de Nantes
      recruiting
      Nantes, France, 44093
    • Hôpital Saint Louis
      recruiting
      Paris, France, 75010
    • Hôpital Pitié Salpétrière
      not yet recruiting
      Paris, France, 75013
    • Hôpital Necker
      recruiting
      Paris, France, 75015
    • CH Joffre
      not yet recruiting
      Perpignan, France, 66046
    • CHU de Poitiers
      not yet recruiting
      Poitiers, France, 86021
    • Centre Henri Becquerel
      recruiting
      Rouen, France, 76038
    • IUCT-Oncopole
      recruiting
      Toulouse, France, 31059
    • Hôpital Bretonneau
      not yet recruiting
      Tours, France, 37000
    • Hôpital de Brabois
      recruiting
      Vandoeuvre les nancy, France, 54550
    • CHU de Nice
      not yet recruiting
      Nice, France, 06202
    • CHU de Nîmes
      not yet recruiting
      Nîmes, France, 30029
    • CHU de Reims
      not yet recruiting
      Reims, France, 51092
    • Hôpital civil
      not yet recruiting
      Strasbourg, France, 67091
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    30 May, 2016
    Updated:
    08 February, 2018
    Participants:
    105
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