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The study is aimed at evaluating the feasibility of a hypomethylating treatment combined with hematopoietic stem cell transplantation in comparison to hematopoietic stem cell transplantation in patients with high-risk myelodysplastic syndrome.
EU CTIS ID: 2023-510515-19-00
What this study is testing
The primary objective of this study has been split in two categories: the feasibility of HSCT (ITT) in patients with HR-MDS with a proportion of bone marrow blasts below 10% and in patients with a proportion of BM blasts equal or greater than 10%.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.