NCT05124288 Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways
| NCT ID | NCT05124288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ciceri Fabio |
| Condition | Acute Myeloid Leukemia, in Relapse |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-07-18 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-07-18 with a primary completion date of 2026-12-20.
⚠ 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
This is a retrospective and prospective non-interventional multicenter observational study. Neither diagnostic approaches nor experimental drugs/procedure will be applied and the samples will take place at the same time as the samples will be taken during routinary clinical practice. The aim of this study is to analyze the immunobiology of Acute Myeloid Leukemia (AML) relapses after allogeneic HSCT for the generation of guidelines and personalized therapeutic pathways.
Eligibility Criteria
Inclusion Criteria: * Adult patients with Acute Myeloid Leukemia, who relapse after allogeneic transplantation from either family or unrelated donors, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood), who have signed the informed consent of the study; * For the coordinating center, all patients who have previously signed informed consent to the "Hematological Neoplasms Biobank" and for which samples, stored in the Biobank are available. * For the other centers, all patients who have previously signed an informed consent, aimed at the prior authorization for the storage of samples in the biobank of the aforementioned center, according to centers own practice, and for which samples, stored in a Biobank, are available. Exclusion Criteria: * Participation in clinical protocols that expressly exclude the possibility of participating in other studies.
Contact & Investigator
Fabio Ciceri, MD
PRINCIPAL INVESTIGATOR
IRCCS Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT05124288 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia, in Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05124288 currently recruiting?
Yes, NCT05124288 is actively recruiting participants. Contact the research team at ciceri.clinicaltrials@hsr.it for enrollment information.
Where is the NCT05124288 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05124288 clinical trial?
NCT05124288 is sponsored by Ciceri Fabio. The principal investigator is Fabio Ciceri, MD at IRCCS Ospedale San Raffaele. The trial plans to enroll 500 participants.
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