Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
Comparison of survival in patients with or without a matched donor at 36 months
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed Informed consent
Classical IPSS intermediate 1 or low myelodysplastic syndrome associated with at least one poor prognosis feature:
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
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
Primary purpose
Allocation
Interventional model
Masking
79 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal