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New treatment option for High-risk MDS
Official title Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
ClinicalTrials.gov ID: NCT04184505
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for high-risk mds.
Also referred to as AZA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Open-label, randomized multicenter phase III non-inferiority study
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
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 ≥3 months;
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...
- 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 ≥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...
- 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:
- prior investigational drugs (within 30 days);
- radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months;
- growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;
- androgenic hormones during the previous 14 days;
- prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS (a previous treatment with Lenalidomide is admitted, provided that lenalidomide had been stopped at least...
The study team makes the final eligibility decision.
Where it's taking place
- Alessandria, Italy
- Ancona, Italy
- Ascoli Piceno, Italy
- Bari, Italy
- Bologna, Italy
- Brescia, Italy
- Brindisi, Italy
- Castelfranco Veneto, Italy
- Catania, Italy
- Cona, Italy
- Cuneo, Italy
- Foggia, Italy
- Latina, Italy
- Lecce, Italy
- Mestre, Italy
- Milan, Italy
- Modena, Italy
- Naples, Italy
- Orbassano, Italy
- Pagani, Italy
+ 16 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alessandria, Italy; Ancona, Italy; Ascoli Piceno, Italy; Bari, Italy; Bologna, Italy; Brescia, Italy and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.