Allogeneic Hematopoietic Stem Cell TransplantationPhase 2/3NCT03596892
Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT
A Phase 2/3 study testing Decitabine, Busulfan (BU) and Cyclophosphamide (CY) in people with Allogeneic Hematopoietic Stem Cell Transplantation and Conditions, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation, Conditions, Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia
- What is being tested?
- Decitabine, Busulfan (BU) and Cyclophosphamide (CY)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Jun 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- MLL+ acute leukemia undergoing allo-HSCT
- 14-65 years
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.
Qifa Liu contact
Qifa Liu contact
China1 site, 1 recruiting
- Recruiting
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Li Xuan, +86-020-62787883, 356135708@qq.com
Qifa Liu
About this study
Official title: Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Read the detailed description
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Conditions, Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia
- Being tested
- Decitabine, Busulfan (BU), Cyclophosphamide (CY)
- Medical subject headings
- Disease
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 -14 and -10.
Busulfan (BU)Drug
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide (CY)Drug
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
| Study group | Role | What they receive |
|---|---|---|
| Decitabine + BUCY | Experimental | For MLL+ acute leukemia undergoing allo-HSCT，Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10； Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. Receives: Drug: Decitabine; Drug: Busulfan (BU); Drug: Cyclophosphamide (CY) |
| BUCY | Active comparator | For MLL+ acute leukemia undergoing allo-HSCT，BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. Receives: Drug: Busulfan (BU); Drug: Cyclophosphamide (CY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate
Measured: 2 year
Secondary outcomes (3)
overall survival (OS)
Measured: 2 year
disease-free survival (DFS)
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.
- First posted24 Jul 2018
- Study startJul 2018 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 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 Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou First People's Hospital, Peking University People's Hospital, Zhujiang Hospital, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596892
- Sponsor's protocol ID
- Dec+BUCYvsBUCY-MLL+ AL-2018
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu Z, Fan Z, Dai M, He H, Jin H, Sun Z, Huang F, Xu N, Liu Q, Li Y, Dong Y, Zhu P, Liu C, Zeng Y, Sun J, Sun R, Xuan L, Liu Q. Decitabine plus busulfan-cyclophosphamide versus busulfan-cyclophosphamide myeloablative conditioning before allogeneic haematopoietic stem cell transplantation for reducing risk of relapse in adult KMT2A-rearranged leukaemia in China: an open-label, multicentre, randomised phase 3 trial. Lancet Haematol. 2026 Nov;13(11):e810-e821. doi: 10.1016/S2352-3026(26)00250-4.
PubMed 42956759
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03596892
- Acronym / sponsor ID
- Dec+BUCYvsBUCY-MLL+ AL-2018
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Conditions, Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 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, Zhujiang Hospital, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Jul 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.
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Detailed description
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decitabine + BUCY | Experimental | Drug: Decitabine, Drug: Busulfan (BU), Drug: Cyclophosphamide (CY)For MLL+ acute leukemia undergoing allo-HSCT，Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10； Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. |
| BUCY | Active comparator | Drug: Busulfan (BU), Drug: Cyclophosphamide (CY)For MLL+ acute leukemia undergoing allo-HSCT，BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- MLL+ acute leukemia undergoing allo-HSCT
- 14-65 years
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 -14 and -10. | Drug | Decitabine + BUCY |
| Busulfan (BU)Busulfan was administered at 3.2 mg/kg/day on days -7 to -4. | Drug | BUCY, Decitabine + BUCY |
| Cyclophosphamide (CY)Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. | Drug | BUCY, Decitabine + BUCY |
Primary outcome
relapse rate
Time frame: 2 year
3 secondary outcomes
overall survival (OS)
Time frame: 2 year
disease-free survival (DFS)
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 24 Jul 2018.
- Derived from this study: PubMed 42956759Hu Z, Fan Z, Dai M, He H, Jin H, Sun Z, Huang F, Xu N, Liu Q, Li Y, Dong Y, Zhu P, Liu C, Zeng Y, Sun J, Sun R, Xuan L, Liu Q. Decitabine plus busulfan-cyclophosphamide versus busulfan-cyclophosphamide myeloablative conditioning before allogeneic haematopoietic stem cell transplantation for reducing risk of relapse in adult KMT2A-rearranged leukaemia in China: an open-label, multicentre, randomised phase 3 trial. Lancet Haematol. 2026 Nov;13(11):e810-e821. doi: 10.1016/S2352-3026(26)00250-4.
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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. This study is not recruiting at the moment.
Qifa Liu contact
Qifa Liu contact
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Decitabine, Busulfan (BU) and Cyclophosphamide (CY) in people with Allogeneic Hematopoietic Stem Cell Transplantation and Conditions, run by Nanfang Hospital, Southern Medical University 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 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 24 Jul 2018. 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 Qifa Liu (liuqifa628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse rate (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 NCT03596892, 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 24 Jul 2018.