Acute B-cell Lymphoblastic LeukemiaPhase 4NCT06339775
Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation
A Phase 4 study testing Blinatumomab in people with Acute B-cell Lymphoblastic Leukemia, run by Suping ZHANG at 1 site in China.
Trial summary
B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab. Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute B-cell 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≤65 years old
- Stable vital signs
- No severe infection
- There was no grade II-IV graft-versus-host disease
- No organ failure
Who cannot join
- Age > 65 years old
- Unstable vital signs
- Complicated with severe infection
- Combined with grade Ⅱ-Ⅳ graft-versus-host disease
- Heart, liver, kidney and other organ failure
- Complicated with central nervous system leukemia
- Allergies to medications in the treatment regimen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhilei BIAN contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, 450000
Suping ZHANG, +8613523510641, zsp198612@163.com
Zhilei BIAN, 037166862272
About this study
Official title: Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation
B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab.
Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI.
Read more
Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.
(MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital.
Read the detailed description
Patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital and received sequential donor lymphocyte infusion （DLI） treatment after relapse. The patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital from September 2023 to December 2026 and received sequential donor lymphocyte infusion （DLI） treatment after relapse were enrolled.
- Age ≤65 years old
- Stable vital signs
- No severe infection
- No grade II-IV graft-versus-host disease
- No organ failure
Exclusion criteria
- Age >65 years old
- Unstable vital signs
- Complicated with severe infection
- Complicated with grade II-IV graft-versus-host disease
- Organ failure such as heart, liver, kidney, etc.
- Complicated with central nervous system leukemia
- Drug allergy to the treatment regimen Treatment regimen B-ALL patients were regularly followed up after allogeneic hematopoietic stem cell transplantation. When relapse occurred, Blinatumomab was given sequentially after DLI, and the second course of treatment was conducted 1-2 months after DLI.
MRD-positive patients were given Blinatumomab 28μg×5-15 days, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）.
Hematologic relapse patients were given Blinatumomab 9μg d1-4,11.66μg d5-7,28μg d8 （a total of 8 to 21 days）, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）. The duration of using Blinatumomab was determined according to the patient's tolerance, economic situation and other comprehensive factors.
Main observation and statistical indicators Overall survival after relapse, disease-free survival, incidence of cytokine release syndrome （CRS）, incidence of acute/chronic graft-versus-host disease （GVHD） after treatment, incidence of infection, incidence of hematological adverse reactions, etc.Compared with patients receiving usual care.
- Conditions
- Acute B-cell Lymphoblastic Leukemia
- Being tested
- Blinatumomab
- Keywords
- Acute B-cell lymphoblastic leukemia, Relapse, allogeneic hematopoietic stem cell transplantation, Blinatumomab
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called donor lymphocyte infusion
patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.
(MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg).
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab followed by donor lymphocyte infusion | Experimental | Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.
(MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg). Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival time of patients with recurrence after treatment
Measured: three years
Disease-free survival
Disease-free survival time after treatment for relapsed patients
Measured: three years
Secondary outcomes (3)
incidence of cytokine release syndrome （CRS）
Recurrent patients received treatment 2 weeks later
Measured: 2 weeks later
Incidence of acute/chronic graft-versus-host disease （GVHD）
Recurrent patients received treatment 100 days later.
Measured: 2 weeks later
hematological adverse reactions Incidence rate
Recurrent patients received treatment 2 weeks later.
Measured: 2 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (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 B-cell 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suping ZHANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suping ZHANG, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Zhilei BIAN, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339775
- Sponsor's protocol ID
- 2024318
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06339775
- Acronym / sponsor ID
- 2024318
- Conditions
- Acute B-cell Lymphoblastic Leukemia
- Keywords
- Acute B-cell lymphoblastic leukemia, Relapse, allogeneic hematopoietic stem cell transplantation, Blinatumomab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suping ZHANGUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Apr 2024 (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.
B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab.
Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI.
Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.
(MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital.
Detailed description
Patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital and received sequential donor lymphocyte infusion （DLI） treatment after relapse. The patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital from September 2023 to December 2026 and received sequential donor lymphocyte infusion （DLI） treatment after relapse were enrolled.
- Age ≤65 years old
- Stable vital signs
- No severe infection
- No grade II-IV graft-versus-host disease
- No organ failure
Exclusion criteria
- Age >65 years old
- Unstable vital signs
- Complicated with severe infection
- Complicated with grade II-IV graft-versus-host disease
- Organ failure such as heart, liver, kidney, etc.
- Complicated with central nervous system leukemia
- Drug allergy to the treatment regimen Treatment regimen B-ALL patients were regularly followed up after allogeneic hematopoietic stem cell transplantation. When relapse occurred, Blinatumomab was given sequentially after DLI, and the second course of treatment was conducted 1-2 months after DLI.
MRD-positive patients were given Blinatumomab 28μg×5-15 days, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）.
Hematologic relapse patients were given Blinatumomab 9μg d1-4,11.66μg d5-7,28μg d8 （a total of 8 to 21 days）, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）. The duration of using Blinatumomab was determined according to the patient's tolerance, economic situation and other comprehensive factors.
Main observation and statistical indicators Overall survival after relapse, disease-free survival, incidence of cytokine release syndrome （CRS）, incidence of acute/chronic graft-versus-host disease （GVHD） after treatment, incidence of infection, incidence of hematological adverse reactions, etc.Compared with patients receiving usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab followed by donor lymphocyte infusion | Experimental | Drug: BlinatumomabPatients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment. (MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg). |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≤65 years old
- Stable vital signs
- No severe infection
- There was no grade II-IV graft-versus-host disease
- No organ failure
Key exclusion criteria (7 listed)
- Age > 65 years old
- Unstable vital signs
- Complicated with severe infection
- Combined with grade Ⅱ-Ⅳ graft-versus-host disease
- Heart, liver, kidney and other organ failure
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: donor lymphocyte infusionpatients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment. (MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg). | Drug | Blinatumomab followed by donor lymphocyte infusion |
Primary outcome
Overall survival
Time frame: three years
Survival time of patients with recurrence after treatment
Disease-free survival
Time frame: three years
Disease-free survival time after treatment for relapsed patients
3 secondary outcomes
incidence of cytokine release syndrome （CRS）
Time frame: 2 weeks later
Incidence of acute/chronic graft-versus-host disease （GVHD）
Time frame: 2 weeks later
hematological adverse reactions Incidence rate
Time frame: 2 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- 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.
Zhilei BIAN contact
Zhilei BIAN principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blinatumomab in people with Acute B-cell Lymphoblastic Leukemia, run by Suping ZHANG 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Apr 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suping ZHANG (+8613523510641, zsp198612@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: three years). The study lists 2 primary outcomes in all. 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 NCT06339775, 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 1 Apr 2024.