B-cell Acute Lymphoblastic LeukemiaPhase 2NCT05559450
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL
A Phase 2 study testing Blinatumomab and Conventional therapy in people with B-cell Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab and Conventional therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to Jan 2026
- Phase
- Phase 2
- 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
- The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
- ECOG score is 0-2.
- Expecting life span is more than 6 months.
- Patients are free from severe organ dysfunction.
Who cannot join
- Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) <30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) >2.5mg/ dL or blood Creatinine clearance rate < 30ml/min.
- Patients are combined with infection or other complications that can not tolerate chemotherapy.
- Patients are suffering from central nervous system/solitary extramedullary leukemia.
- Patients are considered as tumer progression.
- Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
- Pregnant and lactating women will not be included.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Soochow University
Suzhou, Jiangsu, 215000
Xiang Zhang, PhD, 15606133002, zhangxiang@suda.edu.cn
About this study
Official title: A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
Read the detailed description
High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- Blinatumomab, Conventional therapy
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Blinatumomab will be bridged to conventional BUCY conditioning regimen.
Conventional therapyOther
Control group will be given conventional BUCY conditioning regimen.
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab arm | Experimental | On the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day. Receives: Drug: Blinatumomab |
| Conventional therapy | Other | Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The time from randomization to death from any cause.
Measured: From the 1st day to the 720th days after enrollment.
Secondary outcomes (3)
The proportion of patients with negative minimal residual disease (MRD)
Negative MRD is defined as below 10-4 by flow cytometry.
Measured: From the 1st day to the 720th days after enrollment.
Progression-Free Survival (PFS)
It is defined as the total survival of a patient after the hematopoietic stem cell transplantation, until the tumor recurrence or death from any cause.
Measured: From the 1st day to the 720th days after enrollment.
Cumulative incidence of relapse (CIR)
From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.
Measured: From the 1st day to the 720th days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Feb 2022
- Primary completion1 Jan 2024 (estimated)
- Study completionJan 2026 (estimated)
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 B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Zhongda Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First People's Hospital of Changzhou, Wuxi People's Hospital, First Affiliated Hospital of Wannan Medical College
- Responsible party
- Principal investigator, HAN Yue, The First Affiliated Hospital of Soochow University
- Investigators
- Yue Han, MD/PhD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559450
- Sponsor's protocol ID
- 2022019
- Status last verified
- Dec 2021
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22.
PubMed 29358182Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05559450
- Acronym / sponsor ID
- 2022019
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Zhongda Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First People's Hospital of Changzhou, Wuxi People's Hospital, First Affiliated Hospital of Wannan Medical College
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Sep 2022 (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.
To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
Detailed description
High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab arm | Experimental | Drug: BlinatumomabOn the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day. |
| Conventional therapy | Other | Other: Conventional therapyBucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
- ECOG score is 0-2.
- Expecting life span is more than 6 months.
- Patients are free from severe organ dysfunction.
Key exclusion criteria (6 listed)
- Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) <30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) >2.5mg/ dL or blood Creatinine clearance rate < 30ml/min.
- Patients are combined with infection or other complications that can not tolerate chemotherapy.
- Patients are suffering from central nervous system/solitary extramedullary leukemia.
- Patients are considered as tumer progression.
- Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
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 |
|---|---|---|
| BlinatumomabBlinatumomab will be bridged to conventional BUCY conditioning regimen. | Drug | Blinatumomab arm |
| Conventional therapyControl group will be given conventional BUCY conditioning regimen. | Other | Conventional therapy |
Primary outcome
Overall survival (OS)
Time frame: From the 1st day to the 720th days after enrollment.
The time from randomization to death from any cause.
3 secondary outcomes
The proportion of patients with negative minimal residual disease (MRD)
Time frame: From the 1st day to the 720th days after enrollment.
Progression-Free Survival (PFS)
Time frame: From the 1st day to the 720th days after enrollment.
Cumulative incidence of relapse (CIR)
Time frame: From the 1st day to the 720th days after enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 29358182Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
- 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. This study is not recruiting at the moment.
Yue Han, MD/PhD principal investigator
The First Affiliated Hospital of Soochow 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 study testing Blinatumomab and Conventional therapy in people with B-cell Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow 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 4 inclusion and 6 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 29 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Huizhu Kang, MD (18761925608, khz11826@sina.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: From the 1st day to the 720th days after enrollment.). 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 NCT05559450, 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 29 Sep 2022.