LeukemiaPhase 2NCT07105579
Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia
A Phase 2 study testing BITE and DLI in people with Leukemia and Relapse, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia Read more about this study
- Who is it for?
- Ages 14 to 65 years
- What is being tested?
- BITE and DLI
- 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
- Aug 2025to 31 Dec 2027
- Phase
- Phase 2
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14-65 years (inclusive), regardless of gender.
- Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
- Ph-negative B-ALL with high-risk features post-allo-HSCT .
- ≥2 months post-transplant with hematopoietic reconstitution.
- Bone marrow morphology in remission and MRD-negative before enrollment.
- ECOG performance status <3 and Karnofsky score ≥70.
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- No history of grade III/IV graft-versus-host disease (GVHD) and no active GVHD at enrollment.
- Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO).
- Expected survival >3 months.
- Voluntary provision of written informed consent, with ability to understand and comply with study requirements.
Who cannot join
- History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
- Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
- Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) <60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men >450 ms; women >470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
- Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
- Severe hepatic impairment:ALT or total bilirubin (TBIL) >3× upper limit of normal (ULN).
- Severe renal impairment:Serum creatinine (Cr) >2× ULN.24-hour creatinine clearance (Ccr) <50 mL/min.
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- Active infection or uncontrolled bleeding, as assessed by the investigator to preclude safe administration of the study drug.
- History of thrombosis, embolism, cerebral hemorrhage, or other significant vascular events within the past year.
- Psychiatric disorders or other conditions that impair the ability to provide informed consent or comply with study procedures.
- Major organ surgery within the past six weeks.
- Drug abuse or chronic alcoholism that may interfere with study assessments.
- Prior organ transplantation (excluding hematopoietic stem cell transplantation).
- Other conditions deemed by the investigator to make the patient unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou
About this study
Official title: Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia：Phrase II, Exploratory Study
A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
Read the detailed description
Currently, the treatment for Philadelphia chromosome (Ph)-negative adult B-cell acute lymphoblastic leukemia (B-ALL) primarily relies on traditional multi-agent combination chemotherapy. Clinical efficacy is closely associated with patient age, genetic characteristics, chemotherapy sensitivity, and minimal residual disease (MRD) status post-remission. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the most critical curative approach for Ph-negative B-ALL. However, high-risk patients, such as those with refractory/relapsed B-ALL or MRD positivity before transplantation, exhibit significantly higher post-transplant relapse rates, reported at approximately 48%-59%, with a disease-free survival rate of less than 40%.
Multiple studies have reported that blinatumomab achieves complete remission rates of 33-50% in refractory/relapsed Ph-negative B-ALL. Previous research has shown that post-transplant blinatumomab is well-tolerated, with no treatment-related mortality, and the most common severe adverse event being cytopenia. The efficacy of blinatumomab as post-transplant prophylactic therapy depends on T-cell function.
Donor lymphocyte infusion (DLI) is widely used for the prevention and treatment of relapse after allo-HSCT. The investigators prior matched case-control study demonstrated that prophylactic DLI could reduce relapse and improve survival in high-risk acute leukemia patients after haploidentical peripheral blood stem cell transplantation. DLI products are rich in T lymphocytes, which can reverse T-cell exhaustion by altering the composition of cellular subsets in the patient's body, thereby exerting an anti-leukemic effect.
Based on the above rationale, the investigators are conducting this clinical study: a single-arm, phase II, multicenter trial to evaluate the efficacy and safety of blinatumomab combined with donor lymphocyte infusion as maintenance therapy in high-risk Ph-negative B-ALL patients after allo-HSCT.
- Being tested
- BITE and DLI
- Keywords
- hematopoietic stem cell transplantation, Blinatumomab, Donor Lymphocyte Infusion, Ph negative B cell Acute Lymphoblastic Leukemia
- Medical subject headings
- Leukemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BITE and DLIDrug
Blinatumomab dosage:
Cycle 1 (starting at day 60 post-transplant):Days 1-3: 9 μg/day，Days 4-14: 28 μg/day Cycles 2-4:Days 1-14: 28 μg/day Administration method: Continuous 24-hour intravenous infusion, one cycle every 3 months.
DLI eligibility criteria:No history of grade III-IV acute GVHD (aGVHD).No active aGVHD or chronic GVHD (cGVHD) at the time of infusion
DLI dosage:Administered at day 120 post-HSCT, CD3+ cell dose: 1 × 10⁷/kg
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab and Donor Lymphocyte Infusion | Experimental | Not described Receives: Drug: BITE and DLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 2-year leukemia-free survival (LFS) after allo-HSCT.
Measured: 2 years
Secondary outcomes (3)
The 2-year overall survival（OS）
2-year overall survival from transplant
Measured: 2 years
The 2-year cumulative incidence of relapse
Measured: 2-years
The 2-year cumulative incidence of non-relapse mortality(NRM)
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startAug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105579
- Sponsor's protocol ID
- ZJU-HSCT-BITEDLI
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia：Phrase II, Exploratory Study
- ClinicalTrials.gov ID
- NCT07105579
- Acronym / sponsor ID
- ZJU-HSCT-BITEDLI
- Keywords
- hematopoietic stem cell transplantation, Blinatumomab, Donor Lymphocyte Infusion, Ph negative B cell Acute Lymphoblastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Aug 2025 (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 single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
Detailed description
Currently, the treatment for Philadelphia chromosome (Ph)-negative adult B-cell acute lymphoblastic leukemia (B-ALL) primarily relies on traditional multi-agent combination chemotherapy. Clinical efficacy is closely associated with patient age, genetic characteristics, chemotherapy sensitivity, and minimal residual disease (MRD) status post-remission. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the most critical curative approach for Ph-negative B-ALL. However, high-risk patients, such as those with refractory/relapsed B-ALL or MRD positivity before transplantation, exhibit significantly higher post-transplant relapse rates, reported at approximately 48%-59%, with a disease-free survival rate of less than 40%.
Multiple studies have reported that blinatumomab achieves complete remission rates of 33-50% in refractory/relapsed Ph-negative B-ALL. Previous research has shown that post-transplant blinatumomab is well-tolerated, with no treatment-related mortality, and the most common severe adverse event being cytopenia. The efficacy of blinatumomab as post-transplant prophylactic therapy depends on T-cell function.
Donor lymphocyte infusion (DLI) is widely used for the prevention and treatment of relapse after allo-HSCT. The investigators prior matched case-control study demonstrated that prophylactic DLI could reduce relapse and improve survival in high-risk acute leukemia patients after haploidentical peripheral blood stem cell transplantation. DLI products are rich in T lymphocytes, which can reverse T-cell exhaustion by altering the composition of cellular subsets in the patient's body, thereby exerting an anti-leukemic effect.
Based on the above rationale, the investigators are conducting this clinical study: a single-arm, phase II, multicenter trial to evaluate the efficacy and safety of blinatumomab combined with donor lymphocyte infusion as maintenance therapy in high-risk Ph-negative B-ALL patients after allo-HSCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab and Donor Lymphocyte Infusion | Experimental | Drug: BITE and DLI |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age 14-65 years (inclusive), regardless of gender.
- Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
- Ph-negative B-ALL with high-risk features post-allo-HSCT .
- ≥2 months post-transplant with hematopoietic reconstitution.
- Bone marrow morphology in remission and MRD-negative before enrollment.
Key exclusion criteria (13 listed)
- History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
- Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
- Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) <60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men >450 ms; women >470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
- Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
- Severe hepatic impairment:ALT or total bilirubin (TBIL) >3× upper limit of normal (ULN).
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 |
|---|---|---|
| BITE and DLIBlinatumomab dosage: Cycle 1 (starting at day 60 post-transplant):Days 1-3: 9 μg/day，Days 4-14: 28 μg/day Cycles 2-4:Days 1-14: 28 μg/day Administration method: Continuous 24-hour intravenous infusion, one cycle every 3 months. DLI eligibility criteria:No history of grade III-IV acute GVHD (aGVHD).No active aGVHD or chronic GVHD (cGVHD) at the time of infusion DLI dosage:Administered at day 120 post-HSCT, CD3+ cell dose: 1 × 10⁷/kg | Drug | Blinatumomab and Donor Lymphocyte Infusion |
Primary outcome
The 2-year leukemia-free survival (LFS) after allo-HSCT.
Time frame: 2 years
3 secondary outcomes
The 2-year overall survival（OS）
Time frame: 2 years
The 2-year cumulative incidence of relapse
Time frame: 2-years
The 2-year cumulative incidence of non-relapse mortality(NRM)
Time frame: 2-years
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 6 Aug 2025.
- 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.
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 BITE and DLI in people with Leukemia and Relapse, run by First Affiliated Hospital of 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 10 inclusion and 13 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 6 Aug 2025. 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?
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 Yi Luo, MD (86-13666609126, luoyijr@zju.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 2-year leukemia-free survival (LFS) after allo-HSCT. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.