Acute Myeloid LeukemiaPhase 2/3NCT03530085

Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT

A Phase 2/3 study testing Decitabine, Busulfan (BU) and Fludarabine(Flu) in people with Acute Myeloid Leukemia and Allogeneic Hematopoietic Stem Cell Transplantation, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 to 80 years
Conditions the study is for: Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning
What is being tested?: Decitabine, Busulfan (BU) and Fludarabine(Flu)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 15 Jun 2018to 1 Apr 2022
Phase: Phase 2/3
Are there results?: None posted in the registry

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 60 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

AML patients older than 60 years, younger than 80 years
In complete remission before transplantation
With HLA-matched sibling donors

Who cannot join

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
Patients with any conditions not suitable for the trial (investigators' decision)

Trial locations and contacts

1 site in 1 country.

Li Xuan contact

008615521251270

356135708@qq.com

China1 site, 1 recruiting

Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Li Xuan, +86-020-62787883, 356135708@qq.com
Qifa Liu
Recruiting

Other trials in China

About this study

Official title: Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Read the detailed description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Conditions: Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning, Elderly
Being tested: Decitabine, Busulfan (BU), Fludarabine(Flu)
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DecitabineDrug
Decitabine was administered at 20mg/m2/day on days -9 to -7.
Busulfan (BU)Drug
Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
Fludarabine(Flu)Drug
Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.

Study groups in NCT03530085
Study group	Role	What they receive
Dec+Flu+Bu Conditioning Regimen	Experimental	For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7；Fludarabine(Flu) 30mg/m2/day on days -6 to -3；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4). Receives: Drug: Decitabine; Drug: Busulfan (BU); Drug: Fludarabine(Flu)

What is being measured

The primary outcome is the main question the study is designed to answer.

overall survival (OS)
Measured: 2 year

Secondary outcomes (3)

disease-free survival (DFS)
Measured: 2 year
relapse
Measured: 2 year
transplant-related mortality (TRM)
Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20181 Apr 2022

First posted21 May 2018
Study start15 Jun 2018
Primary completion1 Apr 2021 (estimated)
Study completion1 Apr 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03530085
Sponsor's protocol ID: Dec+FB-Elderly AML-2018
Status last verified: Dec 2020
First submitted: 8 May 2018
Last updated: 22 Dec 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Liu Q, Hu Z, Xu N, Jiang Y, Fan Z, Huang F, Lin R, Jin H, Zeng Y, He H, Zhu P, Yu G, Shi P, Sun R, Xu X, Li Z, Zhang Y, Sun J, Wang Y, Xuan L. Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trial. Lancet Reg Health West Pac. 2025 Aug 12;61:101664. doi: 10.1016/j.lanwpc.2025.101664. eCollection 2025 Aug.
PubMed 40831735

Want to know more?

Li Xuan

008615521251270

356135708@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
RecruitingPhase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Active, not recruitingPhase 2
Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance
Acute Myeloid Leukemia
Active, not recruiting
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 3
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
Acute Myeloid Leukemia

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT03530085
Acronym / sponsor ID: Dec+FB-Elderly AML-2018
Conditions: Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning, Elderly
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou First People's Hospital, Peking University People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital
Study start: 15 Jun 2018 (actual)
Primary completion: 1 Apr 2021 (estimated)
Study completion: 1 Apr 2022 (estimated)
First posted: 21 May 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dec+Flu+Bu Conditioning Regimen	Experimental	Drug: Decitabine, Drug: Busulfan (BU), Drug: Fludarabine(Flu)For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7；Fludarabine(Flu) 30mg/m2/day on days -6 to -3；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

AML patients older than 60 years, younger than 80 years
In complete remission before transplantation
With HLA-matched sibling donors

Key exclusion criteria (2 listed)

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
Patients with any conditions not suitable for the trial (investigators' decision)

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
DecitabineDecitabine was administered at 20mg/m2/day on days -9 to -7.	Drug	Dec+Flu+Bu Conditioning Regimen
Busulfan (BU)Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.	Drug	Dec+Flu+Bu Conditioning Regimen
Fludarabine(Flu)Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.	Drug	Dec+Flu+Bu Conditioning Regimen

Primary outcome

overall survival (OS)
Time frame: 2 year

3 secondary outcomes

disease-free survival (DFS)
Time frame: 2 year
relapse
Time frame: 2 year
transplant-related mortality (TRM)
Time frame: 2 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Derived from this study: PubMed 40831735Liu Q, Hu Z, Xu N, Jiang Y, Fan Z, Huang F, Lin R, Jin H, Zeng Y, He H, Zhu P, Yu G, Shi P, Sun R, Xu X, Li Z, Zhang Y, Sun J, Wang Y, Xuan L. Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trial. Lancet Reg Health West Pac. 2025 Aug 12;61:101664. doi: 10.1016/j.lanwpc.2025.101664. eCollection 2025 Aug.
Individual participant dataSharing planned: No

Related trials for Acute Myeloid Leukemia

RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
RecruitingPhase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Active, not recruitingPhase 2
Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance
Acute Myeloid Leukemia
Active, not recruiting
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 3
Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2
Acute Myeloid Leukemia

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. This study is not recruiting at the moment.

Li Xuan contact

008615521251270

356135708@qq.com

Qifa Liu principal investigator

Department of Hematology,Nanfang Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Xuan (008615521251270, 356135708@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (OS) (time frame: 2 year). 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 NCT03530085, which also lists 1 linked publication.

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 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.