Acute Myeloid LeukemiaNCT06111612
Intensive Conditioning withTHI/Bu/Flu/Ara-C in Allo-HSCT for Myeloid Malignancies With Extramedullary Involvement
An observational study of Acute Myeloid Leukemia and Myelodysplastic Neoplasm, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Neoplasm, Chronic Myelomonocytic Leukemia
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 1 Jan 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Outpatient and inpatient patients
Who may be able to join
- Age between 18 and less than 55 years, regardless of gender.
- Criteria for myeloid tumors with extramedullary involvement:
- AML (Acute Myeloid Leukemia) with at least one extramedullary lesion achieving hematological remission (CR1 or CR2) after induction therapy.
- MDS (Myelodysplastic Syndrome) with at least one extramedullary lesion and bone marrow blast percentage ≥ 5% achieving hematological CR after treatment; CMML (Chronic Myelomonocytic Leukemia) with at least one extramedullary lesion (diagnosed according to WHO standards) achieving hematological CR after treatment.
- Control and remission of extramedullary lesions, including those in the central nervous system, testes, skin, and other extramedullary tissues.
- Granulocytic sarcoma with or without bone marrow involvement, and achieving remission after treatment.
Show all 19Show fewer
- Patients must have a suitable hematopoietic stem cell donor:
- Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
- Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and
- DRB1.
- Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2.
- ECOG (Eastern Cooperative Oncology Group) performance status: 0-2.
- Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
- Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
- Cardiac function: Ejection fraction ≥ 50%.
- Baseline oxygen saturation > 92%.
- Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.0 x ULN.
- Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
- Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.
Who cannot join
- History of malignancies other than myeloid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively treated localized prostate cancer or ductal carcinoma in situ.
- ECOG > 2.
- HCT-CI score ≥ 3.
- Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association [NYHA] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.
- Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection.
- Conditions requiring treatment such as grade 2 or higher seizures, paralysis, aphasia, recent severe cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, or schizophrenia.
Show all 11Show fewer
- HIV-infected individuals.
- Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.
- Patients at risk of HBV reactivation, are defined as those who are positive for hepatitis B surface antigen or core antibody without receiving antiviral therapy.
- Pregnant or breastfeeding women.
- Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Xianmin Song, MD, +86 21 63240090 ext. 3175, shongxm@139.com
Xianmin Song, MD
About this study
Official title: Intensive Conditioning Regimen With Thiotepa Combined With Busulfan, Fludarabine and Cytarabine for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myeloid Malignancies With Extramedullary Involvement
This study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with extramedullary involvement. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d from d -9 to d -8 (2 days), fludarabine at 30mg/m2/d from d -7 to d -3 (5 days), cytarabine at 1-1.5g/m2/d from d -7 to d -3 (5 days), and busulfan at 3.2mg/kg/d from d -5 to d -3 (3 days). Conditioning begins on day -9, and donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Neoplasm, Chronic Myelomonocytic Leukemia, Myeloid Sarcoma, Extramedullary Myeloid Tumor
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic, Sarcoma, Myeloid
What is being measured
The primary outcome is the main question the study is designed to answer.
1y and 2y-PFS
1-year and 2-year progression-free survival (PFS) rates post-transplant
Measured: 2023-2027
Secondary outcomes (7)
aGVHD
acute graft-versus-host disease (GVHD) within 180 days post-transplant
Measured: 2023-2025
1y and 2y-CIR
cumulative relapse rates (CIR) at 1 year and 2 years post-transplant
Measured: 2023-2027
1y and 2y-OS
overall survival (OS) at 1 year and 2 years post-transplant
Measured: 2023-2027
GRFS
graft-versus-host disease-free, relapse-free survival (GRFS) at 2 years post-transplant
Measured: 2023-2027
NRM
non-relapse mortality (NRM) at 2 years post-transplant
Measured: 2023-2027
cGVHD
cumulative incidence of chronic GVHD at 2 years post-transplant
Measured: 2023-2027
CMV and EBV reactivation
the incidence of CMV and EBV reactivation within 1 year
Measured: 2023-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start20 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin Song, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111612
- Sponsor's protocol ID
- SHSYXY-202308-THI-BFA
- Status last verified
- Jul 2024
- First submitted
- 27 Oct 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Individual data sharing
- No
Publications
Martin-Subero JI. Predicting leukemia relapse. Nat Med. 2018 Apr 10;24(4):385-387. doi: 10.1038/nm.4529. No abstract available.
PubMed 29634681Elenitoba-Johnson K, Hodges GF, King TC, Wu CD, Medeiros LJ. Extramedullary myeloid cell tumors arising in the setting of chronic myelomonocytic leukemia. A report of two cases. Arch Pathol Lab Med. 1996 Jan;120(1):62-7.
PubMed 8554447Hancock JC, Prchal JT, Bennett JM, Listinsky CM. Trilineage extramedullary myeloid cell tumor in myelodysplastic syndrome. Arch Pathol Lab Med. 1997 May;121(5):520-3.
PubMed 9167610Cankaya H, Ugras S, Dilek I. Head and neck granulocytic sarcoma with acute myeloid leukemia: three rare cases. Ear Nose Throat J. 2001 Apr;80(4):224-6, 228-9.
PubMed 11338646Bakst RL, Tallman MS, Douer D, Yahalom J. How I treat extramedullary acute myeloid leukemia. Blood. 2011 Oct 6;118(14):3785-93. doi: 10.1182/blood-2011-04-347229. Epub 2011 Jul 27.
PubMed 21795742Cribe AS, Steenhof M, Marcher CW, Petersen H, Frederiksen H, Friis LS. Extramedullary disease in patients with acute myeloid leukemia assessed by 18F-FDG PET. Eur J Haematol. 2013 Apr;90(4):273-8. doi: 10.1111/ejh.12085.
PubMed 23470093Su WP. Clinical, histopathologic, and immunohistochemical correlations in leukemia cutis. Semin Dermatol. 1994 Sep;13(3):223-30.
PubMed 7986692Pileri SA, Ascani S, Cox MC, Campidelli C, Bacci F, Piccioli M, Piccaluga PP, Agostinelli C, Asioli S, Novero D, Bisceglia M, Ponzoni M, Gentile A, Rinaldi P, Franco V, Vincelli D, Pileri A Jr, Gasbarra R, Falini B, Zinzani PL, Baccarani M. Myeloid sarcoma: clinico-pathologic, phenotypic and cytogenetic analysis of 92 adult patients. Leukemia. 2007 Feb;21(2):340-50. doi: 10.1038/sj.leu.2404491. Epub 2006 Dec 14.
PubMed 17170724Chevallier P, Mohty M, Lioure B, Michel G, Contentin N, Deconinck E, Bordigoni P, Vernant JP, Hunault M, Vigouroux S, Blaise D, Tabrizi R, Buzyn A, Socie G, Michallet M, Volteau C, Harousseau JL. Allogeneic hematopoietic stem-cell transplantation for myeloid sarcoma: a retrospective study from the SFGM-TC. J Clin Oncol. 2008 Oct 20;26(30):4940-3. doi: 10.1200/JCO.2007.15.6315. Epub 2008 Jul 7.
PubMed 18606981Michel G, Boulad F, Small TN, Black P, Heller G, Castro-Malaspina H, Childs BH, Gillio AP, Papadopoulos EB, Young JW, Kernan NA, O'Reilly RJ. Risk of extramedullary relapse following allogeneic bone marrow transplantation for acute myelogenous leukemia with leukemia cutis. Bone Marrow Transplant. 1997 Jul;20(2):107-12. doi: 10.1038/sj.bmt.1700857.
PubMed 9244412Pui CH, Kalwinsky DK, Schell MJ, Mason CA, Mirro J Jr, Dahl GV. Acute nonlymphoblastic leukemia in infants: clinical presentation and outcome. J Clin Oncol. 1988 Jun;6(6):1008-13. doi: 10.1200/JCO.1988.6.6.1008.
PubMed 3373258Bruserud O, Reikvam H, Kittang AO, Ahmed AB, Tvedt TH, Sjo M, Hatfield KJ. High-dose etoposide in allogeneic stem cell transplantation. Cancer Chemother Pharmacol. 2012 Dec;70(6):765-82. doi: 10.1007/s00280-012-1990-z. Epub 2012 Oct 6.
PubMed 23053272Clift RA, Buckner CD, Appelbaum FR, Sullivan KM, Storb R, Thomas ED. Long-term follow-Up of a randomized trial of two irradiation regimens for patients receiving allogeneic marrow transplants during first remission of acute myeloid leukemia. Blood. 1998 Aug 15;92(4):1455-6. No abstract available.
PubMed 9694737Alatrash G, de Lima M, Hamerschlak N, Pelosini M, Wang X, Xiao L, Kerbauy F, Chiattone A, Rondon G, Qazilbash MH, Giralt SA, de Padua Silva L, Hosing C, Kebriaei P, Zhang W, Nieto Y, Saliba RM, Champlin RE, Andersson BS. Myeloablative reduced-toxicity i.v. busulfan-fludarabine and allogeneic hematopoietic stem cell transplant for patients with acute myeloid leukemia or myelodysplastic syndrome in the sixth through eighth decades of life. Biol Blood Marrow Transplant. 2011 Oct;17(10):1490-6. doi: 10.1016/j.bbmt.2011.02.007. Epub 2011 Feb 18.
PubMed 21338705Sora F, Grazia CD, Chiusolo P, Raiola AM, Bregante S, Mordini N, Olivieri A, Iori AP, Patriarca F, Grisariu S, Terruzzi E, Rambaldi A, Sica S, Bruno B, Angelucci E, Bacigalupo A. Allogeneic Hemopoietic Stem Cell Transplants in Patients with Acute Myeloid Leukemia (AML) Prepared with Busulfan and Fludarabine (BUFLU) or Thiotepa, Busulfan, and Fludarabine (TBF): A Retrospective Study. Biol Blood Marrow Transplant. 2020 Apr;26(4):698-703. doi: 10.1016/j.bbmt.2019.12.725. Epub 2019 Dec 23.
PubMed 31875522
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Conditioning Regimen With Thiotepa Combined With Busulfan, Fludarabine and Cytarabine for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myeloid Malignancies With Extramedullary Involvement
- ClinicalTrials.gov ID
- NCT06111612
- Acronym / sponsor ID
- SHSYXY-202308-THI-BFA
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Neoplasm, Chronic Myelomonocytic Leukemia, Myeloid Sarcoma, Extramedullary Myeloid Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Nov 2023 (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 study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with extramedullary involvement. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d from d -9 to d -8 (2 days), fludarabine at 30mg/m2/d from d -7 to d -3 (5 days), cytarabine at 1-1.5g/m2/d from d -7 to d -3 (5 days), and busulfan at 3.2mg/kg/d from d -5 to d -3 (3 days). Conditioning begins on day -9, and donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Outpatient and inpatient patients
Key inclusion criteria (19 listed)
- Age between 18 and less than 55 years, regardless of gender.
- Criteria for myeloid tumors with extramedullary involvement:
- Patients must have a suitable hematopoietic stem cell donor:
- Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2.
- ECOG (Eastern Cooperative Oncology Group) performance status: 0-2.
Key exclusion criteria (11 listed)
- History of malignancies other than myeloid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively treated localized prostate cancer or ductal carcinoma in situ.
- ECOG > 2.
- HCT-CI score ≥ 3.
- Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association [NYHA] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.
- Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1y and 2y-PFS
Time frame: 2023-2027
1-year and 2-year progression-free survival (PFS) rates post-transplant
7 secondary outcomes
aGVHD
Time frame: 2023-2025
1y and 2y-CIR
Time frame: 2023-2027
1y and 2y-OS
Time frame: 2023-2027
GRFS
Time frame: 2023-2027
NRM
Time frame: 2023-2027
cGVHD
Time frame: 2023-2027
CMV and EBV reactivation
Time frame: 2023-2026
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 22 Jul 2024.
- Background: PubMed 29634681Martin-Subero JI. Predicting leukemia relapse. Nat Med. 2018 Apr 10;24(4):385-387. doi: 10.1038/nm.4529. No abstract available.
- Background: PubMed 8554447Elenitoba-Johnson K, Hodges GF, King TC, Wu CD, Medeiros LJ. Extramedullary myeloid cell tumors arising in the setting of chronic myelomonocytic leukemia. A report of two cases. Arch Pathol Lab Med. 1996 Jan;120(1):62-7.
- Background: PubMed 9167610Hancock JC, Prchal JT, Bennett JM, Listinsky CM. Trilineage extramedullary myeloid cell tumor in myelodysplastic syndrome. Arch Pathol Lab Med. 1997 May;121(5):520-3.
- Background: PubMed 11338646Cankaya H, Ugras S, Dilek I. Head and neck granulocytic sarcoma with acute myeloid leukemia: three rare cases. Ear Nose Throat J. 2001 Apr;80(4):224-6, 228-9.
- Background: PubMed 21795742Bakst RL, Tallman MS, Douer D, Yahalom J. How I treat extramedullary acute myeloid leukemia. Blood. 2011 Oct 6;118(14):3785-93. doi: 10.1182/blood-2011-04-347229. Epub 2011 Jul 27.
- Background: PubMed 23470093Cribe AS, Steenhof M, Marcher CW, Petersen H, Frederiksen H, Friis LS. Extramedullary disease in patients with acute myeloid leukemia assessed by 18F-FDG PET. Eur J Haematol. 2013 Apr;90(4):273-8. doi: 10.1111/ejh.12085.
- Background: PubMed 7986692Su WP. Clinical, histopathologic, and immunohistochemical correlations in leukemia cutis. Semin Dermatol. 1994 Sep;13(3):223-30.
- Background: PubMed 17170724Pileri SA, Ascani S, Cox MC, Campidelli C, Bacci F, Piccioli M, Piccaluga PP, Agostinelli C, Asioli S, Novero D, Bisceglia M, Ponzoni M, Gentile A, Rinaldi P, Franco V, Vincelli D, Pileri A Jr, Gasbarra R, Falini B, Zinzani PL, Baccarani M. Myeloid sarcoma: clinico-pathologic, phenotypic and cytogenetic analysis of 92 adult patients. Leukemia. 2007 Feb;21(2):340-50. doi: 10.1038/sj.leu.2404491. Epub 2006 Dec 14.
- Background: PubMed 18606981Chevallier P, Mohty M, Lioure B, Michel G, Contentin N, Deconinck E, Bordigoni P, Vernant JP, Hunault M, Vigouroux S, Blaise D, Tabrizi R, Buzyn A, Socie G, Michallet M, Volteau C, Harousseau JL. Allogeneic hematopoietic stem-cell transplantation for myeloid sarcoma: a retrospective study from the SFGM-TC. J Clin Oncol. 2008 Oct 20;26(30):4940-3. doi: 10.1200/JCO.2007.15.6315. Epub 2008 Jul 7.
- Background: PubMed 9244412Michel G, Boulad F, Small TN, Black P, Heller G, Castro-Malaspina H, Childs BH, Gillio AP, Papadopoulos EB, Young JW, Kernan NA, O'Reilly RJ. Risk of extramedullary relapse following allogeneic bone marrow transplantation for acute myelogenous leukemia with leukemia cutis. Bone Marrow Transplant. 1997 Jul;20(2):107-12. doi: 10.1038/sj.bmt.1700857.
- Background: PubMed 3373258Pui CH, Kalwinsky DK, Schell MJ, Mason CA, Mirro J Jr, Dahl GV. Acute nonlymphoblastic leukemia in infants: clinical presentation and outcome. J Clin Oncol. 1988 Jun;6(6):1008-13. doi: 10.1200/JCO.1988.6.6.1008.
- Background: PubMed 23053272Bruserud O, Reikvam H, Kittang AO, Ahmed AB, Tvedt TH, Sjo M, Hatfield KJ. High-dose etoposide in allogeneic stem cell transplantation. Cancer Chemother Pharmacol. 2012 Dec;70(6):765-82. doi: 10.1007/s00280-012-1990-z. Epub 2012 Oct 6.
- Individual participant dataSharing planned: No
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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.
Xianmin Song, MD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 and Myelodysplastic Neoplasm, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 19 inclusion and 11 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 22 Jul 2024. 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 China. 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 Xianmin Song, MD (+86 13501672508, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1y and 2y-PFS (time frame: 2023-2027). 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 NCT06111612, which also lists 18 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 22 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.