Acute Myeloid Leukemia, in RelapseGITMO-RELAPSENCT05124288
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
An observational study of Acute Myeloid Leukemia, in Relapse, run by Ciceri Fabio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, in Relapse
- What is being tested?
- Observations on Relapsed AML Allogeneic Transplanted patients
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jul 2022to 20 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort of this study will be composed of adult patients with Acute Myeloid Leukemia, who will relapse after allogeneic transplantation from either familial or unrelated donor, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood). The samples of interest are those taken at the time of post-transplant recurrence at the same time as routine investigations and may be of both medullary blood and peripheral blood, as long as the samples have a percentage of pathological cells equal to at least 5% of cellularity.
Who may be able to join
- 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.
Who cannot join
- Participation in clinical protocols that expressly exclude the possibility of participating in other studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Fabio Ciceri, MD, +39 02-2643-3093, ciceri.clinicaltrials@hsr.it
Stefania Trinca, +39 02-2643-4289, regolatorio.scp@hsr.it
About this study
Official title: Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways
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.
Read the detailed description
Background: The identification of leukemic relapses characterized by the "Human Leukocyte Antigens loss" event or by changes in the expression levels of genes involved in antigen presentation and lymphocyte co-stimulation demonstrate how a complete characterization of disease recurrence is necessary to ensure the patient a treatment that is as personalized and targeted as possible, avoiding the choice of sub-optimal or, sometimes, harmful therapies. Unfortunately, the identification of the post-transplant relapse mechanism is now far from being part of an established clinical routine, mainly due to the lack of quick and easy-to-access diagnostic tools and multicentre studies demonstrating the efficacy of a type of personalized therapeutic approach.
The main objective of the study is to favor, exploiting the consolidated collaboration between the Italian transplant centers belonging to the Italian Group of Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapies (GITMO), the implementation in clinical practice of an in-depth biological study of relapses of leukemia in order to allow an increasingly targeted and effective planning of the therapeutic strategies to be implemented, ensuring better patient survival.
The study is divided into two parts:
- data collection, from clinical standard practice, of patients with relapse of the disease which will allow to standardize the therapeutic management process and will allow us to promote innovative clinical studies on acute myeloid leukemia post allogeneic HSCT, with the ultimate aim of improving the survival of these patients;
- biological substudy that will allow to define the role of the tumor microenvironment in promoting or counteracting the phenomenon of relapse by identifying its specific alterations in the various forms of disease relapse.
- Conditions
- Acute Myeloid Leukemia, in Relapse
- Being tested
- Observations on Relapsed AML Allogeneic Transplanted patients
- Keywords
- Haematopoietic Stem Cell Transplantation, Graft versus Host Disease, Acute Myeloid Leukemia, Human Leukocyte Antigens loss
- Medical subject headings
- Leukemia, Myeloid, Acute, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observations on Relapsed AML Allogeneic Transplanted patientsOther
This is not an interventional clinical study. This is a retrospective/prospective observational study on Relapsed AML Allogenic Transplanted patients. Additional samples will be collected during the standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Acute Myeloid Leukemia relapsed patients | Adult patients (< 18 years old), 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). Receives: Other: Observations on Relapsed AML Allogeneic Transplanted patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
The probability of disease-free survival will be calculated from the transplant infusion time to the date of death, last follow-up and / or disease recurrence / progression.
Measured: From date of transplant infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start18 Jul 2022
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciceri Fabio
- Sponsor type
- University, hospital or other
- Collaborators
- Gruppo Italiano Trapianto di Midollo Osseo, Associazione Italiana per la Ricerca sul Cancro
- Responsible party
- Sponsor-investigator, Ciceri Fabio, IRCCS San Raffaele
- Investigators
- Fabio Ciceri, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124288
- Sponsor's protocol ID
- GITMO-RELAPSE
- Acronym
- GITMO-RELAPSE
- Status last verified
- May 2025
- First submitted
- 4 Nov 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yet to be determined
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways
- ClinicalTrials.gov ID
- NCT05124288
- Acronym / sponsor ID
- GITMO-RELAPSE / GITMO-RELAPSE
- Conditions
- Acute Myeloid Leukemia, in Relapse
- Keywords
- Haematopoietic Stem Cell Transplantation, Graft versus Host Disease, Acute Myeloid Leukemia, Human Leukocyte Antigens loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ciceri FabioUniversity, hospital or other
- Collaborators
- Gruppo Italiano Trapianto di Midollo Osseo, Associazione Italiana per la Ricerca sul Cancro
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The identification of leukemic relapses characterized by the "Human Leukocyte Antigens loss" event or by changes in the expression levels of genes involved in antigen presentation and lymphocyte co-stimulation demonstrate how a complete characterization of disease recurrence is necessary to ensure the patient a treatment that is as personalized and targeted as possible, avoiding the choice of sub-optimal or, sometimes, harmful therapies. Unfortunately, the identification of the post-transplant relapse mechanism is now far from being part of an established clinical routine, mainly due to the lack of quick and easy-to-access diagnostic tools and multicentre studies demonstrating the efficacy of a type of personalized therapeutic approach.
The main objective of the study is to favor, exploiting the consolidated collaboration between the Italian transplant centers belonging to the Italian Group of Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapies (GITMO), the implementation in clinical practice of an in-depth biological study of relapses of leukemia in order to allow an increasingly targeted and effective planning of the therapeutic strategies to be implemented, ensuring better patient survival.
The study is divided into two parts:
- data collection, from clinical standard practice, of patients with relapse of the disease which will allow to standardize the therapeutic management process and will allow us to promote innovative clinical studies on acute myeloid leukemia post allogeneic HSCT, with the ultimate aim of improving the survival of these patients;
- biological substudy that will allow to define the role of the tumor microenvironment in promoting or counteracting the phenomenon of relapse by identifying its specific alterations in the various forms of disease relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Myeloid Leukemia relapsed patients | – | Other: Observations on Relapsed AML Allogeneic Transplanted patientsAdult patients (< 18 years old), 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort of this study will be composed of adult patients with Acute Myeloid Leukemia, who will relapse after allogeneic transplantation from either familial or unrelated donor, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood). The samples of interest are those taken at the time of post-transplant recurrence at the same time as routine investigations and may be of both medullary blood and peripheral blood, as long as the samples have a percentage of pathological cells equal to at least 5% of cellularity.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in clinical protocols that expressly exclude the possibility of participating in other studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observations on Relapsed AML Allogeneic Transplanted patientsThis is not an interventional clinical study. This is a retrospective/prospective observational study on Relapsed AML Allogenic Transplanted patients. Additional samples will be collected during the standard practice. | Other | Acute Myeloid Leukemia relapsed patients |
Primary outcome
Progression-free Survival
Time frame: From date of transplant infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years
The probability of disease-free survival will be calculated from the transplant infusion time to the date of death, last follow-up and / or disease recurrence / progression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided. Yet to be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Ciceri, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, in Relapse, run by Ciceri Fabio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Ciceri, MD (+39 02-2643-3093, ciceri.clinicaltrials@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: From date of transplant infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.