AMLNCT06946602
Conditioning Regimen in Elderly AML Patients Receiving Haplo-HSCT.
A study testing Bu/Flu/Cy/ATG and Bu/Cy/ATG in people with AML and Elderly, run by Peking University People's Hospital at 1 site in China.
Trial summary
Elderly AML patients receiving conventional chemotherapy have poor prognosis. Allo-HSCT offers better long-term survival than chemotherapy, while high TRM limits its use. Current research focuses more on improving conditioning regimens to reduce TRM. Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- Bu/Flu/Cy/ATG and Bu/Cy/ATG
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Oct 2027
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (a)Diagnosed with AML in first complete remission (CR1). (b)Age ≥55 years. (c)Availability of an haploidentical donor, first transplant, no matched sibling or unrelated donor.
- (d)Willingness to provide written informed consent.
Who cannot join
- (a) Uncontrolled active infection. (b) Secondary AML. (c)Refusal to provide 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.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Yuqian Sun, 861088326666, sunyuqian83@hotmail.com
About this study
Official title: Bu/Cy/Flu/ATG Versus Bu/Cy/ATG Conditioning Regimen in Elderly AML Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation: a Prospective, Randomized, Controlled Study
Elderly AML patients receiving conventional chemotherapy have poor prognosis. Allo-HSCT offers better long-term survival than chemotherapy, while high TRM limits its use. Current research focuses more on improving conditioning regimens to reduce TRM. Studies suggest Bu/Flu/Cy/ATG are safer and more effective for elderly AML haplo-HSCT, lowering TRM. However, prospective randomized trials are lacking. This study aims to compare Bu/Flu/Cy/ATG vs. Bu/Cy/ATG to determine if TRM can be reduced in elderly AML undergoing haplo-HSCT.
Read the detailed description
The prognosis of elderly patients with acute myeloid leukemia (AML) undergoing conventional chemotherapy is poor. Compared with chemotherapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve long-term survival in elderly patients. However, the high transplantion-related mortality (TRM) limited its application. Currently, the top priority in transplantation for elderly AML patients is to reduce TRM through methods such as optimizing conditioning regimens, reducing graft-versus-host disease (GVHD), and preventing infections. Present research primarily focuses on optimizing conditioning regimens. Both domestic and international studies, as well as our team's preliminary research, suggest that replacing cyclophosphamide (Cy) with fludarabine (Flu) can reduce toxicity. Earlier prospective single-arm clinical study in our team confirmed that the Bu/Flu/Cy/ATG regimen is a safe and effective conditioning protocol for haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly AML patients. This study aims to use a prospective randomized controlled trial to verify whether the Bu/Flu/Cy/ATG conditioning regimen can reduce TRM compared with the Bu/Cy/ATG regimen in elderly AML patients undergoing haplo-HSCT.
- Being tested
- Bu/Flu/Cy/ATG, Bu/Cy/ATG
- Keywords
- Haplo-HSCT, elderly, AML, RIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bu/Flu/Cy/ATGProcedure or surgery
The Bu/Flu/Cy/ATG conditioning regimen consists of the following components: Ara-C (2 g/m²/day, injected i.v.) on days-10 and-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Flu (30 mg/m²/day, injected i.v.) from day-6 to day-2; Cy (1.0 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2.
Bu/Cy/ATGProcedure or surgery
The Bu/Cy/ATG conditioning regimen consists of the following components: Ara-C (4 g/m²/day, injected i.v.) on day-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Cy (1.8 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2.
| Study group | Role | What they receive |
|---|---|---|
| Bu/Flu/Cy/ATG | Experimental | Not described Receives: Procedure: Bu/Flu/Cy/ATG |
| Bu/Cy/ATG | Active comparator | Not described Receives: Procedure: Bu/Cy/ATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-related mortality (TRM)
TRM is defined as death due to any transplantation-related cause other than disease relapse. Transplant-related mortality will be calculated using a competing risks model.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Secondary outcomes (8)
Toxicity of conditioning
Toxicity of conditioning within 28 days of HSCT can be graded according to Common Terminology Criteria for Adverse Events (CTCAE): 1.Grade 1: Mild toxicity that does not require medical intervention. 2.Grade 2: Moderate toxicity that may require medical intervention. 3.Grade 3: Severe toxicity that requires significant medical intervention, hospitalization, or results in lasting effects. 4.Grade 4: Life-threatening toxicity, potentially requiring intensive care. 5.Grade 5: Death caused by the toxicity reaction.
Measured: From HSCT to the follow-up assessment at 28 days and 100 days post-treatment.
Engraftment
Platelet engraftment was defined as the first of seven consecutive days with a platelet count >20 × 109/L without transfusion support. Neutrophil engraftment was defined as the first of three consecutive days with an ANC > 0.5 × 109/L.
Measured: Platelet engraftment was assessment at 28 days post-transplantation.
GVHD
Acute GVHD was classified as symptom presentation before 100 days after haplo-HSCT and chronic GVHD was classified as symptom presentation >100 days after haplo-HSCT. Each organ (skin, liver, and gut) was staged 1 through 4 for Acute GVHD according to modified criteria based on the schema of the Mount Sinai Acute GVHD International Consortium (MAGIC), and patients were also assigned a grade of acute GVHD (I through IV) based on overall severity. Chronic GVHD was graded in accordance with the National Institutes of Health (NIH) Chronic Graft-versus-Host Disease Consensus Criteria.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Overall Survival
The time from haplo-HSCT to death from any cause in patients with AML. Overall survival will be calculated using the Kaplan-Meier method.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Cumulative Incidence of Relapse
Relapse was defined as disease recurrence.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Leukemia-free survival
Leukemia-free survival (LFS) was defined as the time from transplantation to relapse, disease progression, or death, whichever occurred first.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Event-Free Survival
Event-Free Survival (EFS) was defined as the time from transplantation to relapse, graft failure, death from any cause, or requirement for additional anti-leukemic therapy.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Viral Infection
Detection of CMV-DNA and EBV-DNA in peripheral blood twice a week.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jan 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yuqian, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946602
- Sponsor's protocol ID
- 2025PHB096-001
- Other IDs
- Peking University
- Status last verified
- Sep 2026
- First submitted
- 19 Apr 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santoro N, Labopin M, Ciceri F, Van Lint MT, Nasso D, Blaise D, Arcese W, Tischer J, Bruno B, Ehninger G, Koc Y, Santarone S, Huang XJ, Savani BN, Mohty M, Ruggeri A, Nagler A. Impact of conditioning intensity on outcomes of haploidentical stem cell transplantation for patients with acute myeloid leukemia 45 years of age and over. Cancer. 2019 May 1;125(9):1499-1506. doi: 10.1002/cncr.31941. Epub 2019 Jan 8.
PubMed 30620383Sun YQ, Xu LP, Zhang XH, Liu DH, Chen H, Wang Y, Yan CH, Wang JZ, Wang FR, Zhang YY, Liu KY, Huang XJ. A retrospective comparison of BU-fludarabine and BU-CY regimens in elderly patients or in patients with comorbidities who received unmanipulated haploidentical hematopoietic SCT. Bone Marrow Transplant. 2015 Apr;50(4):601-3. doi: 10.1038/bmt.2014.303. Epub 2015 Jan 19. No abstract available.
PubMed 25599162Huang XJ, Zhu HH, Chang YJ, Xu LP, Liu DH, Zhang XH, Jiang B, Jiang Q, Jiang H, Chen YH, Chen H, Han W, Liu KY, Wang Y. The superiority of haploidentical related stem cell transplantation over chemotherapy alone as postremission treatment for patients with intermediate- or high-risk acute myeloid leukemia in first complete remission. Blood. 2012 Jun 7;119(23):5584-90. doi: 10.1182/blood-2011-11-389809. Epub 2012 Apr 24.
PubMed 22535659Sun YQ, Han TT, Wang Y, Yan CH, Wang FR, Wang ZD, Kong J, Chen YH, Chen H, Han W, Chen Y, Zhang YY, Zhang XH, Xu LP, Liu KY, Huang XJ. Haploidentical Stem Cell Transplantation With a Novel Conditioning Regimen in Older Patients: A Prospective Single-Arm Phase 2 Study. Front Oncol. 2021 Feb 26;11:639502. doi: 10.3389/fonc.2021.639502. eCollection 2021.
PubMed 33718234
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bu/Cy/Flu/ATG Versus Bu/Cy/ATG Conditioning Regimen in Elderly AML Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation: a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06946602
- Acronym / sponsor ID
- 2025PHB096-001
- Keywords
- Haplo-HSCT, elderly, AML, RIC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 307 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 27 Apr 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.
Elderly AML patients receiving conventional chemotherapy have poor prognosis. Allo-HSCT offers better long-term survival than chemotherapy, while high TRM limits its use. Current research focuses more on improving conditioning regimens to reduce TRM. Studies suggest Bu/Flu/Cy/ATG are safer and more effective for elderly AML haplo-HSCT, lowering TRM. However, prospective randomized trials are lacking. This study aims to compare Bu/Flu/Cy/ATG vs. Bu/Cy/ATG to determine if TRM can be reduced in elderly AML undergoing haplo-HSCT.
Detailed description
The prognosis of elderly patients with acute myeloid leukemia (AML) undergoing conventional chemotherapy is poor. Compared with chemotherapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve long-term survival in elderly patients. However, the high transplantion-related mortality (TRM) limited its application. Currently, the top priority in transplantation for elderly AML patients is to reduce TRM through methods such as optimizing conditioning regimens, reducing graft-versus-host disease (GVHD), and preventing infections. Present research primarily focuses on optimizing conditioning regimens. Both domestic and international studies, as well as our team's preliminary research, suggest that replacing cyclophosphamide (Cy) with fludarabine (Flu) can reduce toxicity. Earlier prospective single-arm clinical study in our team confirmed that the Bu/Flu/Cy/ATG regimen is a safe and effective conditioning protocol for haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly AML patients. This study aims to use a prospective randomized controlled trial to verify whether the Bu/Flu/Cy/ATG conditioning regimen can reduce TRM compared with the Bu/Cy/ATG regimen in elderly AML patients undergoing haplo-HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bu/Flu/Cy/ATG | Experimental | Procedure: Bu/Flu/Cy/ATG |
| Bu/Cy/ATG | Active comparator | Procedure: Bu/Cy/ATG |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (a)Diagnosed with AML in first complete remission (CR1). (b)Age ≥55 years. (c)Availability of an haploidentical donor, first transplant, no matched sibling or unrelated donor.
- (d)Willingness to provide written informed consent.
Key exclusion criteria (1 listed)
- (a) Uncontrolled active infection. (b) Secondary AML. (c)Refusal to provide informed consent.
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 |
|---|---|---|
| Bu/Flu/Cy/ATGThe Bu/Flu/Cy/ATG conditioning regimen consists of the following components: Ara-C (2 g/m²/day, injected i.v.) on days-10 and-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Flu (30 mg/m²/day, injected i.v.) from day-6 to day-2; Cy (1.0 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2. | Procedure or surgery | Bu/Flu/Cy/ATG |
| Bu/Cy/ATGThe Bu/Cy/ATG conditioning regimen consists of the following components: Ara-C (4 g/m²/day, injected i.v.) on day-9; Bu (0.8 mg/kg, q6h, injected i.v.) on days -8 to -6; Cy (1.8 g/m²/day, injected i.v.) on days-5 and-4; and ATG (2.5 mg/kg/day) on days-5 to -2. | Procedure or surgery | Bu/Cy/ATG |
Primary outcome
Transplant-related mortality (TRM)
Time frame: From HSCT to the follow-up assessment at 12 months post-treatment.
TRM is defined as death due to any transplantation-related cause other than disease relapse. Transplant-related mortality will be calculated using a competing risks model.
8 secondary outcomes
Toxicity of conditioning
Time frame: From HSCT to the follow-up assessment at 28 days and 100 days post-treatment.
Engraftment
Time frame: Platelet engraftment was assessment at 28 days post-transplantation.
GVHD
Time frame: From HSCT to the follow-up assessment at 12 months post-treatment.
Overall Survival
Time frame: From HSCT to the follow-up assessment at 12 months post-treatment.
Cumulative Incidence of Relapse
Time frame: From HSCT to the follow-up assessment at 12 months post-treatment.
Leukemia-free survival
Time frame: From HSCT to the follow-up assessment at 12 months post-treatment.
Event-Free Survival
Time frame: From HSCT to the follow-up assessment at 12 months post-treatment.
Viral Infection
Time frame: From HSCT to the follow-up assessment at 12 months post-treatment.
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 14 Sep 2026.
- Results publication: PubMed 30620383Santoro N, Labopin M, Ciceri F, Van Lint MT, Nasso D, Blaise D, Arcese W, Tischer J, Bruno B, Ehninger G, Koc Y, Santarone S, Huang XJ, Savani BN, Mohty M, Ruggeri A, Nagler A. Impact of conditioning intensity on outcomes of haploidentical stem cell transplantation for patients with acute myeloid leukemia 45 years of age and over. Cancer. 2019 May 1;125(9):1499-1506. doi: 10.1002/cncr.31941. Epub 2019 Jan 8.
- Results publication: PubMed 25599162Sun YQ, Xu LP, Zhang XH, Liu DH, Chen H, Wang Y, Yan CH, Wang JZ, Wang FR, Zhang YY, Liu KY, Huang XJ. A retrospective comparison of BU-fludarabine and BU-CY regimens in elderly patients or in patients with comorbidities who received unmanipulated haploidentical hematopoietic SCT. Bone Marrow Transplant. 2015 Apr;50(4):601-3. doi: 10.1038/bmt.2014.303. Epub 2015 Jan 19. No abstract available.
- Results publication: PubMed 22535659Huang XJ, Zhu HH, Chang YJ, Xu LP, Liu DH, Zhang XH, Jiang B, Jiang Q, Jiang H, Chen YH, Chen H, Han W, Liu KY, Wang Y. The superiority of haploidentical related stem cell transplantation over chemotherapy alone as postremission treatment for patients with intermediate- or high-risk acute myeloid leukemia in first complete remission. Blood. 2012 Jun 7;119(23):5584-90. doi: 10.1182/blood-2011-11-389809. Epub 2012 Apr 24.
- Results publication: PubMed 33718234Sun YQ, Han TT, Wang Y, Yan CH, Wang FR, Wang ZD, Kong J, Chen YH, Chen H, Han W, Chen Y, Zhang YY, Zhang XH, Xu LP, Liu KY, Huang XJ. Haploidentical Stem Cell Transplantation With a Novel Conditioning Regimen in Older Patients: A Prospective Single-Arm Phase 2 Study. Front Oncol. 2021 Feb 26;11:639502. doi: 10.3389/fonc.2021.639502. eCollection 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bu/Flu/Cy/ATG and Bu/Cy/ATG in people with AML and Elderly, run by Peking University People's Hospital 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 2 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 14 Sep 2026. 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 Yuqian Sun (861088326666, sunyuqian83@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-related mortality (TRM) (time frame: From HSCT to the follow-up assessment at 12 months post-treatment.). 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 NCT06946602, which also lists 4 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 14 Sep 2026.