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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
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

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU D'amiens
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AmiensFranceUnknown status
CHU d Angers
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AngersFranceUnknown status
Centre Hospitalier Victor Dupouy
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ArgenteuilFranceUnknown status
Chu Jean Minjoz
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BesançonFranceUnknown status
Hopital Avicenne
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BobignyFranceUnknown status
CHU de Haut Lévèque
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BordeauxFranceUnknown status
CHRU Côte de Nacre
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CaenFranceUnknown status
CHU Estaing
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Clermont-FerrandFranceUnknown status
CHSF Gilles de Corbeil
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Corbeil-EssonnesFranceUnknown status
Hopital Henri Mondor
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CréteilFranceUnknown status
CHU de Grenoble
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GrenobleFranceUnknown status
CH Le Mans
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Le MansFranceUnknown status
Hopital Huriez
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LilleFranceUnknown status
Hopital Saint Vincent de Paul
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LilleFranceUnknown status
Hopital Dupuytren
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LimogesFranceUnknown status
Centre Hospitalier Lyon Sud
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LyonFranceUnknown status
GHEF Site de Meaux
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MeauxFranceUnknown status
CHRU de Montpellier
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MontpellierFranceUnknown status
CHU de Nantes
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NantesFranceUnknown status
CHU de Nice
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NiceFranceUnknown status
CHU de Nîmes
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NîmesFranceUnknown status
Hopital Pitie-Salpetriere
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ParisFranceUnknown status
Hôpital Cochin
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ParisFranceUnknown status
Hopital Saint Louis
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ParisFranceUnknown status
Hôpital Necker
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ParisFranceUnknown status
CH Joffre
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PerpignanFranceUnknown status
CHU de Poitiers
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PoitiersFranceUnknown status
CH René Dubos
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PontoiseFranceUnknown status
CHU de Reims
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ReimsFranceUnknown status
Hôpital Pontchaillou
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RennesFranceUnknown status
Centre Henri Becquerel
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RouenFranceUnknown status
Institut Curie
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Saint-CloudFranceUnknown status
Institut de Cancérologie Lucien Neuwirth
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Saint-Priest-en-JarezFranceUnknown status
Hopital Civil
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StrasbourgFranceUnknown status
IUCT Oncopôle
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ToulouseFranceUnknown status
Hopital Bretonneau
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ToursFranceUnknown status
Hôpital de Brabois
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Vandœuvre-lès-NancyFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.