Immediate Stem Cell Transplant Versus Re-treatment in High-Risk Acute Myeloid Leukemia
Compares an immediate stem cell transplant with repeat chemotherapy in adults with high-risk leukemia.
Plain-language title generated from the registry record
Registry title: Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia
Key facts
- Where
- Chengdu, Jinan, Shijiazhuang, and Zhengzhou, ChinaSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk acute myeloid leukemia (AML) who have had one round of induction therapy and need a donor stem cell transplant. It compares immediate transplant with more chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- High-risk AML by the 2022 ELN standards, after one cycle of induction therapy; needs allogeneic hematopoietic stem cell transplantation. KPS score above 60.
- Earlier treatment
- Must have had one cycle of induction therapy. Must not have had more than 440 mg/m2 daunorubicin equivalents, and must not have had an earlier allogeneic transplant.
Main reasons for not taking part
- Acute promyelocytic leukemia
- Severe organ dysfunction (heart, lung, liver or kidney)
- Earlier allogeneic transplantation
- AML in the central nervous system
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Where in China
- People's Liberation Army The General Hospital of Western Theater CommandChengdu, ChinaContact: erlie jiangNo longer taking part
- The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation ArmyJinan, ChinaContact: FANG ZHOUNo longer taking part
- Hebei Medical University Second HospitalShijiazhuang, ChinaContact: xuejun zhangNo longer taking part
- Zhengzhou University - First Affiliated HospitalZhengzhou, ChinaContact: weijie caoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06643195
- Record updated
- 30 December 2024
- Original description
This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission (CR) after their first induction therapy is non-inferior to re-treatment with chemotherapy.Read full original descriptionShow less
Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia: a Randomised, Open-label, Phase 2 Clinical Trial.
This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission (CR) after their first induction therapy is non-inferior to re-treatment with chemotherapy.
Inclusion: AML patients aged ≥ 18 years; High-risk AML patients according to the 2022 ELN standards who received one cycle of induction therapy; Requires allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic HSCT and unrelated donor transplant); KPS score greater than 60; Informed consent must be signed before the start of the study procedures; if it is detrimental to the patient's condition for them to sign, the consent may be signed by a legal guardian or immediate family member.
Exclusion: Patient has received more than 440 mg/m2 daunorubicin equivalents. The cumulative dose is calculated by summing up isotoxic daunorubicin-equivalents for daunorubicin, doxorubicin, epirubicin, idarubicin and mitoxantrone. The conversion factors are derived from the comparison of the respective maximum doses. The conversion factor is 1 for daunorubicin, 1 for doxorubicin, 0.6 for epirubicin, 4.6 for idarubicin, and 2.7 for mitoxantrone (see worksheet for calculation); Left ventricular ejection fraction <50%. 2) Patients who receive supplementary continuous oxygen. 3) Serum bilirubin >1.5 x ULN (if not considered Gilbert-Syndrome) or ASAT/ALAT >5 x ULN; Estimated Glomerular Filtration Rate (GFR) < 50 ml/min, where: Estimated GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) 4. History of allogeneic transplantation. 5. Manifestation of AML in the Central Nervous System. 6. Pregnant or breastfeeding women; Acute promyelocytic leukemia; Severe organ dysfunction, defined as:.