Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome Low Risk

  • STATUS
    Recruiting
  • End date
    Jun 26, 2022
  • participants needed
    105
  • sponsor
    Groupe Francophone des Myelodysplasies
Updated on 26 January 2021
anemia
hla-a
cell transplantation
cytopenia
lenalidomide
blood transfusion
vidaza

Summary

Comparison of survival in patients with or without a matched donor at 36 months

Description

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.

Details
Condition miller-dieker syndrome, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), MDS, myelodysplastic syndromes, myelodysplastic syndrome (mds)
Treatment Transplantation
Clinical Study IdentifierNCT02757989
SponsorGroupe Francophone des Myelodysplasies
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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