Acute Lymphoid Leukemia (ALL)Phase 2NCT06930105
Impact of Low-intensity Chemotherapy Combined With Short-course Blinatumomab on Allo-HSCT in Adults With Ph- B-ALL
A Phase 2 study testing Blinatumomab plus Reduced-dose Chemotherapy in people with Acute Lymphoid Leukemia (ALL), run by Xianmin Song, MD.
Trial summary
This single-arm, prospective, multicenter, phase II study will enroll newly diagnosed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients aged 18-60 years. Participants will receive sequential low-intensity chemotherapy followed by a two-week blinatumomab induction therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Lymphoid Leukemia (ALL)
- What is being tested?
- Blinatumomab plus Reduced-dose Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 May 2028
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients (Age 18-60 years ) with an ECOG performance status of 0-2 and HCT-CI score <3.
- 2. Diagnosis: Confirmed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) by:
- Bone marrow morphology
- Cytochemistry
- Immunophenotyping (CD19-positive by flow cytometry, ≥20% positivity on leukemic cells)
- Chromosomal analysis
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- Molecular/genetic testing. 3. Planned allo-HSCT candidates must have an eligible hematopoietic stem cell donor, including:
- HLA-matched sibling donors
- Unrelated donors (9/10 or 10/10 HLA allele-matched by high-resolution typing)
- Haploidentical related donors. 4. No significant organ dysfunction:
- Liver: ALT/AST ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN.
- Kidney: BUN and serum creatinine ≤1.25× ULN.
- Cardiac:
- No acute myocardial infarction or severe arrhythmia on ECG.
- Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; no significant cardiomegaly, valvular disease, or congenital heart defects.
- Pulmonary: FEV1, FVC, and DLCO ≥60% of predicted values. 5. Contraception:
- Men, women of childbearing potential (postmenopausal women must be amenorrheic for ≥12 months), and their partners must use investigator-approved effective contraception during treatment and for ≥12 months after the last study intervention.
- 6. Informed consent: Patients and their legal guardians must provide written informed consent, demonstrate willingness to undergo allo-HSCT, and agree to comply with treatment protocols, follow-up schedules, and laboratory tests.
Who cannot join
- Non-de novo patients(i.e., relapsed/refractory disease).
- BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).
- Uncontrolled active infections or viral diseases:
- Active bacterial, viral, or fungal infections requiring treatment.
- Hepatitis B: HBsAg-positive or HBcAb-positive with detectable HBV DNA in peripheral blood.
- Hepatitis C: HCV antibody-positive with detectable HCV RNA.
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- Syphilis: Positive TRUST test.
- HIV: HIV antibody-positive.
- Major organ dysfunction or comorbidities:
- Cardiovascular:
- Uncontrolled hypertension, hypertensive crisis, or encephalopathy.
- History of congestive heart failure (CHF), unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia).
- Arterial thrombosis within 3 months (e.g., stroke, transient ischemic attack).
- Symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months.
- Coronary angioplasty, defibrillation, or other high-risk cardiovascular procedures.
- Pulmonary: Severe respiratory insufficiency.
- Gastrointestinal: Active bleeding within 3 months.
- Uncontrolled concurrent illnesses that may compromise safety or study integrity.
- Active or untreated central nervous system (CNS) involvement (e.g., CNS leukemia, epilepsy requiring therapy).
- Pregnancy, lactation, or plans for pregnancy within 1 year post-infusion or during the study period.
- Uncontrolled active infections (excluding uncomplicated UTIs or upper respiratory infections).
- Hypersensitivity to blinatumomab or its components.
- Inability to provide informed consent or comply with study procedures.
- Investigator discretion: Any condition deemed to jeopardize patient safety or interfere with study objectives.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Low-Intensity Chemotherapy Combined With Short-Course Blinatumomab on Allo-HSCT in Adults With Newly Diagnosed Ph-B-ALL: A Single-Arm, Prospective, Multicenter, Phase II Study
This single-arm, prospective, multicenter, phase II study will enroll newly diagnosed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients aged 18-60 years. Participants will receive sequential low-intensity chemotherapy followed by a two-week blinatumomab induction therapy.
Treatment Protocol
Read more
- Low-intensity chemotherapy (VIP regimen)
- V (Vincristine): 1.4 mg/m² (max 2 mg) on days 1 and 8.
- I (Idarubicin): 8 mg/m²/day on days 1 and 8.
- P (Prednisone): 60 mg/m²/day (max 100 mg/day) or equivalent dexamethasone dose on days 1-14.
- Sequential induction therapy:
- Blinatumomab administered for 2 weeks following the VIP regimen.
- Consolidation therapy for morphological complete remission (CR)
- Patients achieving CR receive two cycles of consolidation chemotherapy:
- Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone).
- Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate).
- Allogeneic hematopoietic stem cell transplantation (allo-HSCT):
- Patients with multiparameter flow cytometry-confirmed minimal residual disease (MRD)-negative status proceed to allo-HSCT.
Patients achieving morphological complete remission (CR) will undergo two cycles of consolidation chemotherapy. Those with minimal residual disease (MRD)-negative status confirmed by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) will proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 18-month relapse-free survival (RFS) rate, the secondary endpoints were composite response rate (CRc: CR + CR with incomplete hematologic recovery [CRi]), MRD-negative rate (assessed by MFC/NGS),18-month overall survival (OS) post-transplant, non-relapse mortality (NRM), cumulative incidence of acute/chronic graft-versus-host disease (GVHD), cumulative relapse rate and 18-month GVHD-free/relapse-free survival (GRFS) post-transplant.
- Conditions
- Acute Lymphoid Leukemia (ALL)
- Being tested
- Blinatumomab plus Reduced-dose Chemotherapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinatumomab plus Reduced-dose ChemotherapyDrug
Newly diagnosed Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (Ph-negative B-ALL) patients aged 18-60 years were enrolled.
Treatment Protocol
- Low-intensity chemotherapy (VIP regimen)
- V (Vincristine): 1.4 mg/m² (max 2 mg) on days 1 and 8.
- I (Idarubicin): 8 mg/m²/day on days 1 and 8.
- P (Prednisone): 60 mg/m²/day (max 100 mg/day) or equivalent dexamethasone dose on days 1-14.
- Sequential induction therapy:
- Blinatumomab administered for 2 weeks following the VIP regimen.
- Consolidation therapy for morphological complete remission (CR)
- Patients achieving CR receive two cycles of consolidation chemotherapy:
- Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone).
- Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate).
- Allogeneic hematopoietic stem cell transplantation (allo-HSCT):
- Patients with multiparameter flow cytometry-confirmed minimal res
| Study group | Role | What they receive |
|---|---|---|
| Blina combined low-intensity therapy | Experimental | Not described Receives: Drug: Blinatumomab plus Reduced-dose Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS
18-month relapse-free survival (RFS) rate post-allo-HSCT in newly diagnosed Ph- B-ALL patients treated with low-intensity chemotherapy followed by short-course blinatumomab induction.
Measured: three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoid Leukemia (ALL)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xianmin Song, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin song, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930105
- Sponsor's protocol ID
- SHSYXY-Blina-Ph-B ALL-2025
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 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
- Impact of Low-Intensity Chemotherapy Combined With Short-Course Blinatumomab on Allo-HSCT in Adults With Newly Diagnosed Ph-B-ALL: A Single-Arm, Prospective, Multicenter, Phase II Study
- ClinicalTrials.gov ID
- NCT06930105
- Acronym / sponsor ID
- SHSYXY-Blina-Ph-B ALL-2025
- Conditions
- Acute Lymphoid Leukemia (ALL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Xianmin Song, MDUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 16 Apr 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.
This single-arm, prospective, multicenter, phase II study will enroll newly diagnosed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) patients aged 18-60 years. Participants will receive sequential low-intensity chemotherapy followed by a two-week blinatumomab induction therapy.
Treatment Protocol
- Low-intensity chemotherapy (VIP regimen)
- V (Vincristine): 1.4 mg/m² (max 2 mg) on days 1 and 8.
- I (Idarubicin): 8 mg/m²/day on days 1 and 8.
- P (Prednisone): 60 mg/m²/day (max 100 mg/day) or equivalent dexamethasone dose on days 1-14.
- Sequential induction therapy:
- Blinatumomab administered for 2 weeks following the VIP regimen.
- Consolidation therapy for morphological complete remission (CR)
- Patients achieving CR receive two cycles of consolidation chemotherapy:
- Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone).
- Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate).
- Allogeneic hematopoietic stem cell transplantation (allo-HSCT):
- Patients with multiparameter flow cytometry-confirmed minimal residual disease (MRD)-negative status proceed to allo-HSCT.
Patients achieving morphological complete remission (CR) will undergo two cycles of consolidation chemotherapy. Those with minimal residual disease (MRD)-negative status confirmed by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) will proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 18-month relapse-free survival (RFS) rate, the secondary endpoints were composite response rate (CRc: CR + CR with incomplete hematologic recovery [CRi]), MRD-negative rate (assessed by MFC/NGS),18-month overall survival (OS) post-transplant, non-relapse mortality (NRM), cumulative incidence of acute/chronic graft-versus-host disease (GVHD), cumulative relapse rate and 18-month GVHD-free/relapse-free survival (GRFS) post-transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blina combined low-intensity therapy | Experimental | Drug: Blinatumomab plus Reduced-dose Chemotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Patients (Age 18-60 years ) with an ECOG performance status of 0-2 and HCT-CI score <3.
- 2. Diagnosis: Confirmed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) by:
- Bone marrow morphology
- Cytochemistry
- Immunophenotyping (CD19-positive by flow cytometry, ≥20% positivity on leukemic cells)
Key exclusion criteria (24 listed)
- Non-de novo patients(i.e., relapsed/refractory disease).
- BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).
- Uncontrolled active infections or viral diseases:
- Major organ dysfunction or comorbidities:
- Uncontrolled concurrent illnesses that may compromise safety or study integrity.
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 plus Reduced-dose ChemotherapyNewly diagnosed Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (Ph-negative B-ALL) patients aged 18-60 years were enrolled. Treatment Protocol 1. Low-intensity chemotherapy (VIP regimen) * V (Vincristine): 1.4 mg/m² (max 2 mg) on days 1 and 8. * I (Idarubicin): 8 mg/m²/day on days 1 and 8. * P (Prednisone): 60 mg/m²/day (max 100 mg/day) or equivalent dexamethasone dose on days 1-14. 2. Sequential induction therapy: * Blinatumomab administered for 2 weeks following the VIP regimen. 3. Consolidation therapy for morphological complete remission (CR) * Patients achieving CR receive two cycles of consolidation chemotherapy: * Cycle 1: VDCP regimen (Vincristine, Daunorubicin, Cyclophosphamide, Prednisone). * Cycle 2: VP + HD-MTX regimen (Vincristine, Prednisone + High-Dose Methotrexate). 4. Allogeneic hematopoietic stem cell transplantation (allo-HSCT): * Patients with multiparameter flow cytometry-confirmed minimal res | Drug | Blina combined low-intensity therapy |
Primary outcome
RFS
Time frame: three year
18-month relapse-free survival (RFS) rate post-allo-HSCT in newly diagnosed Ph- B-ALL patients treated with low-intensity chemotherapy followed by short-course blinatumomab induction.
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.
Xianmin song study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blinatumomab plus Reduced-dose Chemotherapy in people with Acute Lymphoid Leukemia (ALL), run by Xianmin Song, MD.
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 18 inclusion and 24 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: opening soon, 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.
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 xia shao (15216632623, maizidemaidi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS (time frame: three 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 6 Aug 2025.