CTIS2023-510515-19-00
Recruiting
Phase 1
Prospective randomized study on the feasibility of allogeneic stem cell transplantation in higher-risk-myelodysplastic syndromes, performed upfront or preceded by azacitidine or conventional chemotherapy, according to the BM-blast proportion (ACROBAT trial). MDS0519 - MDS0519
Fondazione Gimema Franco Mandelli Onlus0 sites274 target enrollmentJune 4, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Higher-risk-myelodysplastic syndromes
- Sponsor
- Fondazione Gimema Franco Mandelli Onlus
- Enrollment
- 274
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with newly diagnosed higher\-risk MDS, including IPSS Intermediate\-2 and high, and IPSS\-R intermediate to very\-high, Age 18\-70 years, Previously untreated for HR\-MDS, HSCT – eligible, Life expectancy greater than or equal to 3 months, Signed written informed consent according to ICH/EU/GCP and national local laws, Eastern Cooperative Oncology Group Performance Status Grade of 0\-2
Exclusion Criteria
- •Acute myeloid leukaemia with \>20% blasts in BM or peripheral blood (PB), concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma), severe renal, cardiac, liver or lung impairment, pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period; Women of childbearing potential and men must agree to use effective contraception during and up to 3 months after treatment with azacitidine., HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis, clinically relevant neurological or psychiatric diseases, hypersensitivity (known or suspected) to AZA, prior Treatments: a) prior investigational drugs (within 30 days); b) radiotherapy, chemotherapy, or cytotoxic therapy for non\-MDS conditions within the previous 6 months; c) growth factors (EPO, G\-CSF or GM\-CSF) during the previous 21 days; d) androgenic hormones during the previous 14 days; e) prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS.
Outcomes
Primary Outcomes
Not specified
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