ALL (Acute B-Lymphoblastic Leukemia)Phase 1NCT07677878
Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
A Phase 1 study testing Blinatumomab Injection and Donor Lymphocyte Infusion (DLI) in people with ALL (Acute B-Lymphoblastic Leukemia), run by Liping Dou at 1 site in China.
Trial summary
This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ALL (Acute B-Lymphoblastic Leukemia)
- What is being tested?
- Blinatumomab Injection and Donor Lymphocyte Infusion (DLI)
- 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 Dec 2024to 1 Dec 2028
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures.
- 2) Age: <70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:
- >CR1 status
- Pre-transplant MRD+ status
- Ph-like subtype
- KMT2A rearrangement
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- Other high-risk cytogenetic/genetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders.
- 8) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.
- 10) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).
Who cannot join
- 1) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).
- 2) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD: Patients with active infection or active graft-versus-host disease (GVHD).
- 4) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.
- 5) Impaired consent/compliance: Patients unable to provide informed consent or comply with procedures due to psychiatric/neurological disorders.
- 6) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.
- 7) Organ dysfunction:
- Liver: ALT or AST > 2.5 × ULN; Total bilirubin > 2 × ULN
- Kidney: Serum creatinine > ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liping Dou, Dr. contact
About this study
Official title: A Single-arm, Open-label, Phase I Clinical Study of Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.
Read the detailed description
This study is a single-center, prospective, single-arm Phase I clinical trial. Since July 2023, 12 patients with high-risk acute B-lymphoblastic leukemia who underwent allogeneic hematopoietic stem cell transplantation were enrolled at the Department of Hematology, the PLA General Hospital . Patients were enrolled after 45d for MSD-HSCT, and after 60d for URD/Haplo donor-HSCT. The maintenance regimen combined blinatumomab (9 µg/day × 7 days) and donor lymphocyte infusion (DLI, CD3+ cells 1× 10⁵/kg). The first cycle was given within the first 3 months after allogeneic HCT and then at approximately 6, 9, and 12 months following transplant. The safety and efficacy of this regimen were analyzed. Patients were premedicated with dexamethasone prior to the start of each cycle. The study was approved by the Ethics Committee of the PLA General Hospital.
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia)
- Being tested
- Blinatumomab Injection, Donor Lymphocyte Infusion (DLI)
- Keywords
- high-risk B-cell ALL, Blinatumomab, donor lymphocyte infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinatumomab InjectionDrug
blinatumomab 9ug d1-7, 28ug d8-14
Donor Lymphocyte Infusion (DLI)Other
CD3+cell 1×10^5/kg
| Study group | Role | What they receive |
|---|---|---|
| BLINA+DLI | Experimental | blinatumomab 9ug d1-7, 28ug d8-14, DLI ( CD3+cell 1×10^5/kg) Receives: Drug: Blinatumomab Injection; Other: Donor Lymphocyte Infusion (DLI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year progression-free-survival
the percentage of patients who remain alive and whose disease has not gotten relapse one full year after they started treatment.
Measured: 1 year
Secondary outcomes (4)
1 year aGVHD rate
Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) The cumulative incidences of aGvHD was defined as the number and the ratio of the participants with aGVHD.
Measured: 100 days after transplantation
1 year cGVHD rate
Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) cGvHD was diagnosed and graded according to the 2014 National Institutes of Health (NIH) consensus criteria: mild, moderate or severe respectively.
Measured: 365 days after transplantation
Nonrelapse mortality (NRM)
Defined as the proportion of subjects who died due to causes other than malignancy relapse
Measured: 365 days after transplantation
Overall survival (OS)
Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause
Measured: 365 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Dec 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL (Acute B-Lymphoblastic Leukemia)Studies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liping Dou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liping Dou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677878
- Sponsor's protocol ID
- BLINADLISTUDY
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Phase I Clinical Study of Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
- ClinicalTrials.gov ID
- NCT07677878
- Acronym / sponsor ID
- BLINADLISTUDY
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia)
- Keywords
- high-risk B-cell ALL, Blinatumomab, donor lymphocyte infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liping DouUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 1 Jul 2026 (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.
This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.
Detailed description
This study is a single-center, prospective, single-arm Phase I clinical trial. Since July 2023, 12 patients with high-risk acute B-lymphoblastic leukemia who underwent allogeneic hematopoietic stem cell transplantation were enrolled at the Department of Hematology, the PLA General Hospital . Patients were enrolled after 45d for MSD-HSCT, and after 60d for URD/Haplo donor-HSCT. The maintenance regimen combined blinatumomab (9 µg/day × 7 days) and donor lymphocyte infusion (DLI, CD3+ cells 1× 10⁵/kg). The first cycle was given within the first 3 months after allogeneic HCT and then at approximately 6, 9, and 12 months following transplant. The safety and efficacy of this regimen were analyzed. Patients were premedicated with dexamethasone prior to the start of each cycle. The study was approved by the Ethics Committee of the PLA General Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLINA+DLI | Experimental | Drug: Blinatumomab Injection, Other: Donor Lymphocyte Infusion (DLI)blinatumomab 9ug d1-7, 28ug d8-14, DLI ( CD3+cell 1×10^5/kg) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures.
- 2) Age: <70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:
- 8) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.
- 10) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).
Key exclusion criteria (8 listed)
- 1) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).
- 2) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD: Patients with active infection or active graft-versus-host disease (GVHD).
- 4) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.
- 5) Impaired consent/compliance: Patients unable to provide informed consent or comply with procedures due to psychiatric/neurological disorders.
- 6) Recent major surgery: Patients who underwent major organ surgery within the past 6 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 |
|---|---|---|
| Blinatumomab Injectionblinatumomab 9ug d1-7, 28ug d8-14 | Drug | BLINA+DLI |
| Donor Lymphocyte Infusion (DLI)CD3+cell 1×10^5/kg | Other | BLINA+DLI |
Primary outcome
1 year progression-free-survival
Time frame: 1 year
the percentage of patients who remain alive and whose disease has not gotten relapse one full year after they started treatment.
4 secondary outcomes
1 year aGVHD rate
Time frame: 100 days after transplantation
1 year cGVHD rate
Time frame: 365 days after transplantation
Nonrelapse mortality (NRM)
Time frame: 365 days after transplantation
Overall survival (OS)
Time frame: 365 days after transplantation
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 Jul 2026.
- 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.
Liping Dou, Dr. contact
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 Injection and Donor Lymphocyte Infusion (DLI) in people with ALL (Acute B-Lymphoblastic Leukemia), run by Liping Dou 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 9 inclusion and 8 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 Jul 2026. 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?
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 Lu Wang (86-10-66937079, wangludophine@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year progression-free-survival (time frame: 1 year). 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 1 Jul 2026.