Acute Myeloid Leukaemia (AML)SHARPNCT06845592
Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia
A study testing total marrow/lymphoid irradiation in people with Acute Myeloid Leukaemia (AML) and Acute Lymphoblastic Leukemia ALL, run by University Of Perugia at 1 site in Italy.
Trial summary
The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukaemia (AML), Acute Lymphoblastic Leukemia ALL, High Risk Leukaemia
- What is being tested?
- total marrow/lymphoid irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 25 Feb 2025to Jan 2031
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML patients
- Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.
- Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.
- Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
- Age ≥ 18 and ≤ 65 years
- ECOG ≤ 2
Show all 18Show fewer
- HCT-CI ≤ 4 (51,52)
- Absence of relevant psychiatric diseases
- Signature of the informed consent
- ALL patients
- Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
- Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
- Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
- Age ≥ 18 and ≤ 65 years
- ECOG ≤ 2
- HCT-CI ≤ 4
- Absence of relevant psychiatric diseases
- Signature of the informed consent
Who cannot join
- AML patients
- AML in CR MRD-
- AML with > 5% peripheral blasts or bone marrow infiltration ≥ 30%
- Age < 18 years or > 65 years
- ECOG > 2
- Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
Show all 16Show fewer
- Pregnancy
- No signature of the informed consent
- ALL patients
- ALL with > 5% peripheral blasts or bone marrow infiltration ≥30%
- Philadelphia positive ALL
- Age < 18 years or > 65 years
- ECOG > 2
- Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
- Pregnancy
- No signature of the informed consent
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
Università degli Studi di Perugia
Perugia, PG, 06100
Antonio Pierini, MD, PhD, 3355477611, antonio.pierini@unipg.it
About this study
Official title: SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia
The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.
- Conditions
- Acute Myeloid Leukaemia (AML), Acute Lymphoblastic Leukemia ALL, High Risk Leukaemia, Leukaemia Relapse
- Being tested
- total marrow/lymphoid irradiation
- Keywords
- AML, ALL, SHARP, Total marrow/lymphoid irradiation, Treg, Tcon, Relapse
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total marrow/lymphoid irradiationRadiation
Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| TMLI based contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation | Experimental | All enrolled patients will receive a 20Gy-TMLI based conditioning regimen followed by the infusion of donor graft and Treg/Tcon adoptive immunotherapy Receives: Radiation: total marrow/lymphoid irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants free from disease 2 years after HSCT
The primary objective of the study is to reduce the incidence of disease relapse after irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched or haploidentical donors in high-risk acute leukemia patients.
Measured: 2 years
Secondary outcomes (3)
Number of participants that have reached engraftment 45 days after HSCT
The study will also evaluate the impact of the allogeneic transplantation from HLA-matched or haploidentical donors with irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy on major transplantation outcomes in high-risk acute leukemia patients such as full donor type engraftment.
Measured: 45 days
Number of participants that developed grade ≥ 2 acute GvHD
The study will also evaluate the impact of the allogeneic transplantation from HLA-matched or haploidentical donors with irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy on major transplantation outcomes in high-risk acute leukemia patients such as grade ≥ 2 acute GvHD.
Measured: 2 years
Number of participants free from chronic GvHD 2 years after HSCT
The study will also evaluate the impact of the allogeneic transplantation from HLA-matched or haploidentical donors with irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy on major transplantation outcomes in high-risk acute leukemia patients such as chronic GvHD.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start25 Feb 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukaemia (AML)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Simon's Minimax two-stage design has been chosen for predicting number of patients and duration of the study. Such design allows the investigator to early stop patient enrollment in case of unexpected futility.
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Pierini, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845592
- Sponsor's protocol ID
- SHARP
- Acronym
- SHARP
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cordonnier C, Einarsdottir S, Cesaro S, Di Blasi R, Mikulska M, Rieger C, de Lavallade H, Gallo G, Lehrnbecher T, Engelhard D, Ljungman P; European Conference on Infections in Leukaemia group. Vaccination of haemopoietic stem cell transplant recipients: guidelines of the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis. 2019 Jun;19(6):e200-e212. doi: 10.1016/S1473-3099(18)30600-5. Epub 2019 Feb 8.
PubMed 30744963El Fakih R, Hashmi SK, Ciurea SO, Luznik L, Gale RP, Aljurf M. Post-transplant cyclophosphamide use in matched HLA donors: a review of literature and future application. Bone Marrow Transplant. 2020 Jan;55(1):40-47. doi: 10.1038/s41409-019-0547-8. Epub 2019 May 14.
PubMed 31089284Patil S, Potter V, Mohty M. Review of conditioning regimens for haplo-identical donor transplants using post-transplant cyclophosphamide in recipients of G-CSF mobilised peripheral stem cell. Cancer Treat Rev. 2020 Sep;89:102071. doi: 10.1016/j.ctrv.2020.102071. Epub 2020 Jul 15.
PubMed 32717620Chistolini P, Cossu G, De Luca M, Marazzi M, Mavilio F, Migliaccio G, et al. LINEE GUIDA PER L'INGEGNERIA DEI TESSUTI E LA TERAPIA CELLULARE. Not DellIstituto Super Sanità. 1999 May 1;Vol. 12:1-8
Stern M, Ruggeri L, Mancusi A, Bernardo ME, de Angelis C, Bucher C, Locatelli F, Aversa F, Velardi A. Survival after T cell-depleted haploidentical stem cell transplantation is improved using the mother as donor. Blood. 2008 Oct 1;112(7):2990-5. doi: 10.1182/blood-2008-01-135285. Epub 2008 May 20.
PubMed 18492955Ruggeri L, Capanni M, Urbani E, Perruccio K, Shlomchik WD, Tosti A, Posati S, Rogaia D, Frassoni F, Aversa F, Martelli MF, Velardi A. Effectiveness of donor natural killer cell alloreactivity in mismatched hematopoietic transplants. Science. 2002 Mar 15;295(5562):2097-100. doi: 10.1126/science.1068440.
PubMed 11896281Ciurea SO, Cao K, Fernandez-Vina M, Kongtim P, Malki MA, Fuchs E, Luznik L, Huang XJ, Ciceri F, Locatelli F, Aversa F, Castagna L, Bacigalupo A, Martelli M, Blaise D, Handgretinger R, Roy DC, O'Donnell P, Bashey A, Lazarus HM, Ballen K, Savani BN, Mohty M, Nagler A. The European Society for Blood and Marrow Transplantation (EBMT) Consensus Guidelines for the Detection and Treatment of Donor-specific Anti-HLA Antibodies (DSA) in Haploidentical Hematopoietic Cell Transplantation. Bone Marrow Transplant. 2018 May;53(5):521-534. doi: 10.1038/s41409-017-0062-8. Epub 2018 Jan 15.
PubMed 29335625van der Velden VH, Panzer-Grumayer ER, Cazzaniga G, Flohr T, Sutton R, Schrauder A, Basso G, Schrappe M, Wijkhuijs JM, Konrad M, Bartram CR, Masera G, Biondi A, van Dongen JJ. Optimization of PCR-based minimal residual disease diagnostics for childhood acute lymphoblastic leukemia in a multi-center setting. Leukemia. 2007 Apr;21(4):706-13. doi: 10.1038/sj.leu.2404535. Epub 2007 Feb 8.
PubMed 17287857van der Velden VH, Cazzaniga G, Schrauder A, Hancock J, Bader P, Panzer-Grumayer ER, Flohr T, Sutton R, Cave H, Madsen HO, Cayuela JM, Trka J, Eckert C, Foroni L, Zur Stadt U, Beldjord K, Raff T, van der Schoot CE, van Dongen JJ; European Study Group on MRD detection in ALL (ESG-MRD-ALL). Analysis of minimal residual disease by Ig/TCR gene rearrangements: guidelines for interpretation of real-time quantitative PCR data. Leukemia. 2007 Apr;21(4):604-11. doi: 10.1038/sj.leu.2404586. Epub 2007 Feb 8.
PubMed 17287850Elia L, Mancini M, Moleti L, Meloni G, Buffolino S, Krampera M, De Rossi G, Foa R, Cimino G. A multiplex reverse transcriptase-polymerase chain reaction strategy for the diagnostic molecular screening of chimeric genes: a clinical evaluation on 170 patients with acute lymphoblastic leukemia. Haematologica. 2003 Mar;88(3):275-9.
PubMed 12651265Pierce E, Mautner B, Mort J, Blewett A, Morris A, Keng M, El Chaer F. MRD in ALL: Optimization and Innovations. Curr Hematol Malig Rep. 2022 Aug;17(4):69-81. doi: 10.1007/s11899-022-00664-6. Epub 2022 May 26.
PubMed 35616771Jung SH, Lee T, Kim K, George SL. Admissible two-stage designs for phase II cancer clinical trials. Stat Med. 2004 Feb 28;23(4):561-9. doi: 10.1002/sim.1600.
PubMed 14755389Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
PubMed 2702835Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005 Oct 15;106(8):2912-9. doi: 10.1182/blood-2005-05-2004. Epub 2005 Jun 30.
PubMed 15994282Duarte RF, Labopin M, Bader P, Basak GW, Bonini C, Chabannon C, Corbacioglu S, Dreger P, Dufour C, Gennery AR, Kuball J, Lankester AC, Lanza F, Montoto S, Nagler A, Peffault de Latour R, Snowden JA, Styczynski J, Yakoub-Agha I, Kroger N, Mohty M; European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2019. Bone Marrow Transplant. 2019 Oct;54(10):1525-1552. doi: 10.1038/s41409-019-0516-2. Epub 2019 Apr 5.
PubMed 30953028
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia
- ClinicalTrials.gov ID
- NCT06845592
- Acronym / sponsor ID
- SHARP / SHARP
- Conditions
- Acute Myeloid Leukaemia (AML), Acute Lymphoblastic Leukemia ALL, High Risk Leukaemia, Leukaemia Relapse
- Keywords
- AML, ALL, SHARP, Total marrow/lymphoid irradiation, Treg, Tcon, Relapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 25 Feb 2025 (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.
The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Simon's Minimax two-stage design has been chosen for predicting number of patients and duration of the study. Such design allows the investigator to early stop patient enrollment in case of unexpected futility.
| Arm | Type | Receives |
|---|---|---|
| TMLI based contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation | Experimental | Radiation: total marrow/lymphoid irradiationAll enrolled patients will receive a 20Gy-TMLI based conditioning regimen followed by the infusion of donor graft and Treg/Tcon adoptive immunotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- AML patients
- ALL patients
- Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
- Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
- Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
Key exclusion criteria (16 listed)
- AML patients
- ALL patients
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 |
|---|---|---|
| total marrow/lymphoid irradiationCombination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation | Radiation | TMLI based contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation |
Primary outcome
Number of participants free from disease 2 years after HSCT
Time frame: 2 years
The primary objective of the study is to reduce the incidence of disease relapse after irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched or haploidentical donors in high-risk acute leukemia patients.
3 secondary outcomes
Number of participants that have reached engraftment 45 days after HSCT
Time frame: 45 days
Number of participants that developed grade ≥ 2 acute GvHD
Time frame: 2 years
Number of participants free from chronic GvHD 2 years after HSCT
Time frame: 2 years
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 4 Mar 2025.
- Background: PubMed 30744963Cordonnier C, Einarsdottir S, Cesaro S, Di Blasi R, Mikulska M, Rieger C, de Lavallade H, Gallo G, Lehrnbecher T, Engelhard D, Ljungman P; European Conference on Infections in Leukaemia group. Vaccination of haemopoietic stem cell transplant recipients: guidelines of the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis. 2019 Jun;19(6):e200-e212. doi: 10.1016/S1473-3099(18)30600-5. Epub 2019 Feb 8.
- Background: PubMed 31089284El Fakih R, Hashmi SK, Ciurea SO, Luznik L, Gale RP, Aljurf M. Post-transplant cyclophosphamide use in matched HLA donors: a review of literature and future application. Bone Marrow Transplant. 2020 Jan;55(1):40-47. doi: 10.1038/s41409-019-0547-8. Epub 2019 May 14.
- Background: PubMed 32717620Patil S, Potter V, Mohty M. Review of conditioning regimens for haplo-identical donor transplants using post-transplant cyclophosphamide in recipients of G-CSF mobilised peripheral stem cell. Cancer Treat Rev. 2020 Sep;89:102071. doi: 10.1016/j.ctrv.2020.102071. Epub 2020 Jul 15.
- BackgroundChistolini P, Cossu G, De Luca M, Marazzi M, Mavilio F, Migliaccio G, et al. LINEE GUIDA PER L'INGEGNERIA DEI TESSUTI E LA TERAPIA CELLULARE. Not DellIstituto Super Sanità. 1999 May 1;Vol. 12:1-8
- Background: PubMed 18492955Stern M, Ruggeri L, Mancusi A, Bernardo ME, de Angelis C, Bucher C, Locatelli F, Aversa F, Velardi A. Survival after T cell-depleted haploidentical stem cell transplantation is improved using the mother as donor. Blood. 2008 Oct 1;112(7):2990-5. doi: 10.1182/blood-2008-01-135285. Epub 2008 May 20.
- Background: PubMed 11896281Ruggeri L, Capanni M, Urbani E, Perruccio K, Shlomchik WD, Tosti A, Posati S, Rogaia D, Frassoni F, Aversa F, Martelli MF, Velardi A. Effectiveness of donor natural killer cell alloreactivity in mismatched hematopoietic transplants. Science. 2002 Mar 15;295(5562):2097-100. doi: 10.1126/science.1068440.
- Background: PubMed 29335625Ciurea SO, Cao K, Fernandez-Vina M, Kongtim P, Malki MA, Fuchs E, Luznik L, Huang XJ, Ciceri F, Locatelli F, Aversa F, Castagna L, Bacigalupo A, Martelli M, Blaise D, Handgretinger R, Roy DC, O'Donnell P, Bashey A, Lazarus HM, Ballen K, Savani BN, Mohty M, Nagler A. The European Society for Blood and Marrow Transplantation (EBMT) Consensus Guidelines for the Detection and Treatment of Donor-specific Anti-HLA Antibodies (DSA) in Haploidentical Hematopoietic Cell Transplantation. Bone Marrow Transplant. 2018 May;53(5):521-534. doi: 10.1038/s41409-017-0062-8. Epub 2018 Jan 15.
- Background: PubMed 17287857van der Velden VH, Panzer-Grumayer ER, Cazzaniga G, Flohr T, Sutton R, Schrauder A, Basso G, Schrappe M, Wijkhuijs JM, Konrad M, Bartram CR, Masera G, Biondi A, van Dongen JJ. Optimization of PCR-based minimal residual disease diagnostics for childhood acute lymphoblastic leukemia in a multi-center setting. Leukemia. 2007 Apr;21(4):706-13. doi: 10.1038/sj.leu.2404535. Epub 2007 Feb 8.
- Background: PubMed 17287850van der Velden VH, Cazzaniga G, Schrauder A, Hancock J, Bader P, Panzer-Grumayer ER, Flohr T, Sutton R, Cave H, Madsen HO, Cayuela JM, Trka J, Eckert C, Foroni L, Zur Stadt U, Beldjord K, Raff T, van der Schoot CE, van Dongen JJ; European Study Group on MRD detection in ALL (ESG-MRD-ALL). Analysis of minimal residual disease by Ig/TCR gene rearrangements: guidelines for interpretation of real-time quantitative PCR data. Leukemia. 2007 Apr;21(4):604-11. doi: 10.1038/sj.leu.2404586. Epub 2007 Feb 8.
- Background: PubMed 12651265Elia L, Mancini M, Moleti L, Meloni G, Buffolino S, Krampera M, De Rossi G, Foa R, Cimino G. A multiplex reverse transcriptase-polymerase chain reaction strategy for the diagnostic molecular screening of chimeric genes: a clinical evaluation on 170 patients with acute lymphoblastic leukemia. Haematologica. 2003 Mar;88(3):275-9.
- Background: PubMed 35616771Pierce E, Mautner B, Mort J, Blewett A, Morris A, Keng M, El Chaer F. MRD in ALL: Optimization and Innovations. Curr Hematol Malig Rep. 2022 Aug;17(4):69-81. doi: 10.1007/s11899-022-00664-6. Epub 2022 May 26.
- Background: PubMed 14755389Jung SH, Lee T, Kim K, George SL. Admissible two-stage designs for phase II cancer clinical trials. Stat Med. 2004 Feb 28;23(4):561-9. doi: 10.1002/sim.1600.
Related trials for Acute Myeloid Leukaemia (AML)
Active, not recruiting
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Acute Leukemia, Acute Myeloid Leukemia (AML)
RecruitingObservational study
A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
Acute Myeloid Leukaemia (AML), Follicular Lymphoma ( FL)
Not yet recruitingPhase 2
Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in AML
Acute Myeloid Leukaemia (AML)
RecruitingPhase 2
Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker
Acute Myeloid Leukemia (AML), Acute Myeloid Leukaemia (AML)
Enrolling by invitationPhase 2
RVU120 Rollover Study
Advanced Solid Tumors, Acute Myeloid Leukaemia (AML)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total marrow/lymphoid irradiation in people with Acute Myeloid Leukaemia (AML) and Acute Lymphoblastic Leukemia ALL, run by University Of Perugia 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 18 inclusion and 16 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 4 Mar 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 Antonio Pierini (+393355477611 ext. +39, antonio.pierini@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants free from disease 2 years after HSCT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06845592, which also lists 63 linked publications.
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 4 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.