NCT04184505 Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)
| NCT ID | NCT04184505 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Condition | High-risk MDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2020-11-27 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 274 participants in total. It began in 2020-11-27 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Open-label, randomized multicenter phase III non-inferiority study
Eligibility Criteria
Inclusion Criteria: 1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high 2. Age 18-70 years 3. Previously untreated for HR-MDS 4. HSCT - eligible 5. Life expectancy ≥3 months; 6. Signed written informed consent according to ICH/EU/GCP and national local laws 7. Eastern Cooperative Oncology Group Performance Status Grade of 0-2 Exclusion Criteria: 1. Acute myeloid leukaemia with \>20% blasts in BM or peripheral blood (PB); 2. concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma); 3. severe renal, cardiac, liver or lung impairment; 4. 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. 5. HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis; 6. clinically relevant neurological or psychiatric diseases; 7. hypersensitivity (known or suspected) to AZA; 8. prior Treatments: 1. prior investigational drugs (within 30 days); 2. radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months; 3. growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days; 4. androgenic hormones during the previous 14 days; 5. 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 60 days before enrolment).
Contact & Investigator
Voso
PRINCIPAL INVESTIGATOR
AOU POLICLINICO TOR VERGATA - ROMA - UOC TRAPIANTO CELLULE STAMINALI
Frequently Asked Questions
Who can join the NCT04184505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying High-risk MDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04184505 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 274 participants.
Is NCT04184505 currently recruiting?
Yes, NCT04184505 is actively recruiting participants. Contact the research team at p.fazi@gimema.it for enrollment information.
Where is the NCT04184505 trial being conducted?
This trial is being conducted at Alessandria, Italy, Ancona, Italy, Ascoli Piceno, Italy, Bari, Italy and 11 additional locations.
Who is sponsoring the NCT04184505 clinical trial?
NCT04184505 is sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. The principal investigator is Voso at AOU POLICLINICO TOR VERGATA - ROMA - UOC TRAPIANTO CELLULE STAMINALI. The trial plans to enroll 274 participants.