Acute Lymphoblastic LeukemiaPhase 1NCT06125106
Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab
A Phase 1 study testing Blinatumomab in people with Acute Lymphoblastic Leukemia, run by Zhejiang University at 1 site in China.
Trial summary
A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2023to 1 Feb 2026
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as acute B-ALL with CD19+ according to the 2022 WHO classification criteria. After induction and intensified chemotherapy, complete hematological remission was achieved, but MRD was positive by flow cytometry;
- Age range from 18 to 70 years old, regardless of gender;
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points;
- Female patients of childbearing age who had a negative pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until their last visit;
- Organ function is normal, and the following laboratory indicators are met within one week of enrollment: creatinine clearance rate ≥ 60 mL/min (according to the Cockcroft Fault formula); AST and ALT ≤ 3 × Upper limit of normal value range (ULN), total bilirubin ≤ 2 × ULN; Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;
- Life expectancy greater than 8 weeks;
- Voluntarily sign an informed consent form to understand and comply with the requirements of the study.
Who cannot join
- Failure to achieve complete hematological remission, including residual extramedullary infiltration;
- Previously received hematopoietic stem cell transplantation;
- Received systemic chemotherapy within 2 weeks;
- Previously received treatment with Blinatumomab;
- Have a history of central nervous system leukemia or present with central nervous system leukemia;
- Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc;
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- Currently suffering from clinically significant active cardiovascular diseases, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined according to the New York Heart Association (NYHA) functional classification (see Appendix 1), or having a history of myocardial infarction within 6 months prior to screening;
- Chronic obstructive pulmonary disease with whole lung dysfunction;
- Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes);
- Concomitant arteriovenous thrombosis or hypercoagulable state;
- Known human immunodeficiency virus (HIV) infection, or chronic infection of hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) beyond drug control;
- Pregnant or lactating women;
- Severe allergies to other monoclonal antibodies in the past;
- Those who are unable to understand, comply with the research protocol or sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310000
He Huang, MD, 86-13605714822, hehuangyu@126.com
Yongxian Hu, MD, +8615957162012, huyongxian2000@aliyun.com
About this study
A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab
Read the detailed description
This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Blinatumomab
- Keywords
- Minimal Residual Disease, Allogeneic hematopoietic stem cell transplantation, Blinatumomab
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called HSCT
Haploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab Group | Experimental | Haploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-Free Survival
Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause.
Measured: At Year 1
Secondary outcomes (6)
Overall Survival
Overall survival (OS) is defined as the time from transplantation to death
Measured: At Year 1
Cumulative Incidence of Relapse
The time from the date of transplantation to disease recurrence:
Disease recurrence, defined as one of the following:
Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
Measured: At Year 1
Non-relapse Mortality
NRM was defined as death after transplant that was not preceded by recurrent or progressive malignancy.
Measured: At Year 1
Minimal Residual Disease
Minimal residual disease is a small number of cancer cells left in the body after treatment.
Measured: At Year 1
acute graft versus host disease
assessment of acute GVHD
Measured: At Day 100
chornic graft versus host disease
assessment of chronic GVHD
Measured: At Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start16 Nov 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2026 (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 Lymphoblastic 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125106
- Sponsor's protocol ID
- IIT20230044C-R1
- Status last verified
- Oct 2023
- First submitted
- 5 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davis 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab
- ClinicalTrials.gov ID
- NCT06125106
- Acronym / sponsor ID
- IIT20230044C-R1
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Minimal Residual Disease, Allogeneic hematopoietic stem cell transplantation, Blinatumomab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 16 Nov 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 9 Nov 2023 (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.
A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab
Detailed description
This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab Group | Experimental | Drug: BlinatumomabHaploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed as acute B-ALL with CD19+ according to the 2022 WHO classification criteria. After induction and intensified chemotherapy, complete hematological remission was achieved, but MRD was positive by flow cytometry;
- Age range from 18 to 70 years old, regardless of gender;
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points;
- Female patients of childbearing age who had a negative pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until their last visit;
- Organ function is normal, and the following laboratory indicators are met within one week of enrollment: creatinine clearance rate ≥ 60 mL/min (according to the Cockcroft Fault formula); AST and ALT ≤ 3 × Upper limit of normal value range (ULN), total bilirubin ≤ 2 × ULN; Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;
Key exclusion criteria (14 listed)
- Failure to achieve complete hematological remission, including residual extramedullary infiltration;
- Previously received hematopoietic stem cell transplantation;
- Received systemic chemotherapy within 2 weeks;
- Previously received treatment with Blinatumomab;
- Have a history of central nervous system leukemia or present with central nervous system leukemia;
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 |
|---|---|---|
| BlinatumomabAlso: HSCTHaploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation. | Drug | Blinatumomab Group |
Primary outcome
Progress-Free Survival
Time frame: At Year 1
Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause.
6 secondary outcomes
Overall Survival
Time frame: At Year 1
Cumulative Incidence of Relapse
Time frame: At Year 1
Non-relapse Mortality
Time frame: At Year 1
Minimal Residual Disease
Time frame: At Year 1
acute graft versus host disease
Time frame: At Day 100
chornic graft versus host disease
Time frame: At Year 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blinatumomab in people with Acute Lymphoblastic Leukemia, run by Zhejiang 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 7 inclusion and 14 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 9 Nov 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jimin Shi (+8613657119907, jiminshi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-Free Survival (time frame: At Year 1). 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 NCT06125106, 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 9 Nov 2023.