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

G

Groupe Francophone des Myelodysplasies

Status

Active, not recruiting

Conditions

MDS

Treatments

Other: transplantation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02757989
2015-A00292-47 (Other Identifier)
MDS-ALLO-RISK

Details and patient eligibility

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

79 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Signed Informed consent 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

1. MDS classified according to classical IPSS as intermediate 2 or High risk 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

79 participants in 2 patient groups

Patients with donor
Experimental group
Description:
Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling)
Treatment:
Other: transplantation
Patients without donor
No Intervention group
Description:
Patients without a matched donor

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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