Allogeneic Hematopoietic Stem Cell TransplantationPhase 3NCT02670252
BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT
A Phase 3 study testing Busulfan (BU), Cyclophosphamide (CY) and Total Body Irradiation (TBI) in people with Allogeneic Hematopoietic Stem Cell Transplantation and Busulfan, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice between BU-based or TBI-based conditioning regimens still remains controversial. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation
- What is being tested?
- Busulfan (BU), Cyclophosphamide (CY) and Total Body Irradiation (TBI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Feb 2022
- Phase
- Phase 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
- Standard-risk ALL
- Achieving CR1
- Undergoing HLA-matched allo-HSCT (related or unrelated)
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.
China1 site
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Busulfan Plus Cyclophosphamide vs Total Body Irradiation Plus Cyclophosphamide Conditioning Regimen for Standard-risk Acute Lymphocytic Leukemia Undergoing HLA-matched Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice between BU-based or TBI-based conditioning regimens still remains controversial. In this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Read the detailed description
Allo-HSCT appears to be an efficient tool to cure standard-risk ALL in CR1. The conditioning regimen with BUCY or TBICY is considered as the standard myeloablative regimen for ALL in CR1, but the choice between BU-based or TBI-based conditioning regimen still remains controversial.In order to analyze the impact of conditioning regimen on long-term survival and relapse, in this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation, Acute Lymphocytic Leukemia
- Being tested
- Busulfan (BU), Cyclophosphamide (CY), Total Body Irradiation (TBI)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Total Body Irradiation (TBI)Radiation
Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.
| Study group | Role | What they receive |
|---|---|---|
| BUCY | Experimental | For standard-risk ALL undergoing HLA-matched allo-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2. Receives: Drug: Busulfan (BU); Drug: Cyclophosphamide (CY) |
| TBICY | Active comparator | For standard-risk ALL undergoing HLA-matched allo-HSCT，TBICY conditioning regimen was 4.5 Gy TBI/day on days -5 and -4；CY 60 mg/kg/day on days -3 and -2. Receives: Drug: Cyclophosphamide (CY); Radiation: Total Body Irradiation (TBI) |
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)
leukemia relapse rate
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 posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2020
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou First People's Hospital, Zhujiang Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Xiangya Hospital of Central South University, The Seventh Affiliated Hospital of Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Second Provincial General Hospital, The Affiliated Hospital of Qingdao University, First People's Hospital of Chenzhou, Guangzhou Panyu Central Hospital
- 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
- NCT02670252
- Sponsor's protocol ID
- BUCY vs TBICY-ALL-2016
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2016
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
de Berranger E, Cousien A, Petit A, Peffault de Latour R, Galambrun C, Bertrand Y, Salmon A, Rialland F, Rohrlich PS, Vannier JP, Lutz P, Yakouben K, Duhamel A, Bruno B, Michel G, Dalle JH. Impact on long-term OS of conditioning regimen in allogeneic BMT for children with AML in first CR: TBI+CY versus BU+CY: a report from the Societe Francaise de Greffe de Moelle et de Therapie Cellulaire. Bone Marrow Transplant. 2014 Mar;49(3):382-8. doi: 10.1038/bmt.2013.185. Epub 2013 Dec 9.
PubMed 24317131Zhang H, Fan Z, Huang F, Han L, Xu Y, Xu N, Deng L, Wang S, Lin D, Luo X, Zhang Q, Liu X, Li X, Liang X, Xie S, Qu H, Yu S, Zhou H, Shi P, Xuan L, Lin R, Liu H, Jin H, Sun J, Liu Q. Busulfan Plus Cyclophosphamide Versus Total Body Irradiation Plus Cyclophosphamide for Adults Acute B Lymphoblastic Leukemia: An Open-Label, Multicenter, Phase III Trial. J Clin Oncol. 2023 Jan 10;41(2):343-353. doi: 10.1200/JCO.22.00767. Epub 2022 Sep 9.
PubMed 36084276
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Busulfan Plus Cyclophosphamide vs Total Body Irradiation Plus Cyclophosphamide Conditioning Regimen for Standard-risk Acute Lymphocytic Leukemia Undergoing HLA-matched Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02670252
- Acronym / sponsor ID
- BUCY vs TBICY-ALL-2016
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation, Acute Lymphocytic Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Guangzhou First People's Hospital, Zhujiang Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Xiangya Hospital of Central South University, The Seventh Affiliated Hospital of Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Second Provincial General Hospital, The Affiliated Hospital of Qingdao University, First People's Hospital of Chenzhou, Guangzhou Panyu Central Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice between BU-based or TBI-based conditioning regimens still remains controversial. In this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Detailed description
Allo-HSCT appears to be an efficient tool to cure standard-risk ALL in CR1. The conditioning regimen with BUCY or TBICY is considered as the standard myeloablative regimen for ALL in CR1, but the choice between BU-based or TBI-based conditioning regimen still remains controversial.In order to analyze the impact of conditioning regimen on long-term survival and relapse, in this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUCY | Experimental | Drug: Busulfan (BU), Drug: Cyclophosphamide (CY)For standard-risk ALL undergoing HLA-matched allo-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2. |
| TBICY | Active comparator | Drug: Cyclophosphamide (CY), Radiation: Total Body Irradiation (TBI)For standard-risk ALL undergoing HLA-matched allo-HSCT，TBICY conditioning regimen was 4.5 Gy TBI/day on days -5 and -4；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 (3 listed)
- Standard-risk ALL
- Achieving CR1
- Undergoing HLA-matched allo-HSCT (related or unrelated)
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 |
|---|---|---|
| Busulfan (BU)Busulfan was administered at 3.2 mg/kg/day on days -7 to -4. | Drug | BUCY |
| Cyclophosphamide (CY)Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. | Drug | BUCY, TBICY |
| Total Body Irradiation (TBI)Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4. | Radiation | TBICY |
Primary outcome
overall survival (OS)
Time frame: 2 year
3 secondary outcomes
leukemia relapse rate
Time frame: 2 year
disease-free survival (DFS)
Time frame: 2 year
transplant-related mortality (TRM)
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 24317131de Berranger E, Cousien A, Petit A, Peffault de Latour R, Galambrun C, Bertrand Y, Salmon A, Rialland F, Rohrlich PS, Vannier JP, Lutz P, Yakouben K, Duhamel A, Bruno B, Michel G, Dalle JH. Impact on long-term OS of conditioning regimen in allogeneic BMT for children with AML in first CR: TBI+CY versus BU+CY: a report from the Societe Francaise de Greffe de Moelle et de Therapie Cellulaire. Bone Marrow Transplant. 2014 Mar;49(3):382-8. doi: 10.1038/bmt.2013.185. Epub 2013 Dec 9.
- Derived from this study: PubMed 36084276Zhang H, Fan Z, Huang F, Han L, Xu Y, Xu N, Deng L, Wang S, Lin D, Luo X, Zhang Q, Liu X, Li X, Liang X, Xie S, Qu H, Yu S, Zhou H, Shi P, Xuan L, Lin R, Liu H, Jin H, Sun J, Liu Q. Busulfan Plus Cyclophosphamide Versus Total Body Irradiation Plus Cyclophosphamide for Adults Acute B Lymphoblastic Leukemia: An Open-Label, Multicenter, Phase III Trial. J Clin Oncol. 2023 Jan 10;41(2):343-353. doi: 10.1200/JCO.22.00767. Epub 2022 Sep 9.
- Individual participant dataSharing planned: Yes
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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 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 3 study testing Busulfan (BU), Cyclophosphamide (CY) and Total Body Irradiation (TBI) in people with Allogeneic Hematopoietic Stem Cell Transplantation and Busulfan, 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 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: finished, as of the sponsor's last update on 8 Apr 2022. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT02670252, which also lists 2 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 8 Apr 2022.