B Acute Lymphoblastic Leukemia, Philadelphia Chromosome NegativePhase 2FLOWNCT07564453
Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
A Phase 2 study testing Blinatumomab, Induction Chemotherapy and Hyper-CVAD in people with B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
- What is being tested?
- Blinatumomab, Induction Chemotherapy and Hyper-CVAD
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Jun 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥15 years and ≤65 years.
- Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20%
- De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days)
- ECOG performance status score 0-3.
- Liver function: Total bilirubin ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3×ULN; aspartate transaminase (AST) ≤ 3×ULN; (leukemic infiltration is excluded).
- Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/min
- Able to understand and voluntarily participate in the study, and provide written informed consent
Who cannot join
- Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL
- T-cell acute lymphoblastic leukemia
- Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion
- Acute mixed phenotype acute leukemia (MPAL)
- Central nervous system (CNS) leukemia
- HIV infection
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- Positive HBV-DNA or HCV-RNA
- New York Heart Association (NYHA) functional class ≥ II, or other conditions deemed unsuitable for enrollment by the investigator
- Pregnant or lactating patients
- Patients who refuse to enroll in the study
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Jing Lu, 86+0512-67781137, gloriajlu@163.com
About this study
This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A/B) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy.
The primary endpoint is 2-year relapse-free survival (RFS). Secondary endpoints include 2-year overall survival (OS), the proportion and time to achieve complete response (CRc), and the proportion and time to achieve minimal residual disease (MRD) negativity.
The trial plans to enroll 101 patients aged 15-65 years to demonstrate improved survival outcomes compared with historical controls .
- Being tested
- Blinatumomab, Induction Chemotherapy, Hyper-CVAD, Allogeneic hematopoietic stem cell transplantation, CAR-T cell therapy
- Keywords
- B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Blinatumomab
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabBiological
Induction phase: 9 µg/day on days 8-14, 28 µg/day on days 15-21; If D22 BM not CR/CRi, continue Blinatumomab for next 2 weeks of 28 µg/day; Consolidation phase: 28 µg/day for 28 days.
Induction ChemotherapyDrug
Reduced-dose induction regimen:
Idarubicin 8 mg/m², intravenous, day 1; Vindesine 3 mg/m² (max 4 mg), intravenous, day 1; Dexamethasone 9 mg/m²/day, intravenous, days 1-7. Combined with blinatumomab
Hyper-CVADDrug
Alternating intensive consolidation chemotherapy:
Hyper-CVAD-A: Cyclophosphamide ,Vincristine , Doxorubicin , Dexamethasone ; Hyper-CVAD-B: Methotrexate , Cytarabine . Alternated with CD19-CART and blinatumomab
Allogeneic hematopoietic stem cell transplantationProcedure or surgery
Allogeneic hematopoietic stem cell transplantation, performed after consolidation therapy in patients with KMT2A rearrangement, TP53 mutation, persistent MRD positivity or MRD recurrence
CAR-T cell therapyBiological
CD19-CART is administered sequentially in the consolidation phase:
First infusion : Following the first course of blinatumomab (28 µg/day, IV, days 1-28) before subsequent Hyper-CVAD chemotherapy.
Second infusion : After completion of alternating Hyper-CVAD and blinatumomab consolidation cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm:Blinatumomab + Chemotherapy | Experimental | Patients receive reduced-dose chemotherapy combined with blinatumomab for induction, followed by alternating Hyper-CVAD(A/B) chemotherapy, blinatumomab and sequential CD19-directed CAR-T therapy for consolidation. Patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence)receive allogeneic hematopoietic stem cell transplantation. Receives: Biological: Blinatumomab; Drug: Induction Chemotherapy; Drug: Hyper-CVAD; Procedure: Allogeneic hematopoietic stem cell transplantation; Biological: CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year relapse-free survival (RFS)
Defined as the time from enrollment to relapse, death from any cause, or last follow-up, whichever occurs first.
Measured: From enrollment through 2 years post-last patient enrolled
Secondary outcomes (3)
2-year overall survival (OS)
Defined as the time from enrollment to death from any cause or last follow-up, whichever occurs first.
Measured: From enrollment through 2 years post-last patient enrolled
Composite Complete Remission (CR/CRi) Rate after Induction Therapy
Proportion of patients achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction phase.CRc is evaluated at: 1) Day 22 after initial induction therapy; 2) After re-induction with blinatumomab for 2 weeks (for patients not achieving CRc at Day 22)
Measured: From randomization to 2 cycles of induction before consolidation therapy(100 days)
Minimal Residual Disease (MRD) Negativity Rate
Proportion of patients achieving MRD negativity (detected by next-generation sequencing, NGS, sensitivity ≥10-⁵) at multiple time points: after first Hyper-CVAD-B chemotherapy, after second Hyper-CVAD-B chemotherapy, and after CD19-CART2 therapy. MRD negativity is defined as <10-⁵ leukemic blasts in bone marrow.
Measured: From randomization to 2 cycles of induction before consolidation therapy(100 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Acute Lymphoblastic Leukemia, Philadelphia Chromosome NegativeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Suning, The First Affiliated Hospital of Soochow University
- Investigators
- Suning Chen, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564453
- Sponsor's protocol ID
- ALL-03
- Acronym
- FLOW
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07564453
- Acronym / sponsor ID
- FLOW / ALL-03
- Keywords
- B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Blinatumomab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 May 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 is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A/B) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy.
The primary endpoint is 2-year relapse-free survival (RFS). Secondary endpoints include 2-year overall survival (OS), the proportion and time to achieve complete response (CRc), and the proportion and time to achieve minimal residual disease (MRD) negativity.
The trial plans to enroll 101 patients aged 15-65 years to demonstrate improved survival outcomes compared with historical controls .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm:Blinatumomab + Chemotherapy | Experimental | Biological: Blinatumomab, Drug: Induction Chemotherapy, Drug: Hyper-CVAD, Procedure: Allogeneic hematopoietic stem cell transplantation, Biological: CAR-T cell therapyPatients receive reduced-dose chemotherapy combined with blinatumomab for induction, followed by alternating Hyper-CVAD(A/B) chemotherapy, blinatumomab and sequential CD19-directed CAR-T therapy for consolidation. Patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence)receive allogeneic hematopoietic stem cell transplantation. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥15 years and ≤65 years.
- Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20%
- De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days)
- ECOG performance status score 0-3.
- Liver function: Total bilirubin ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3×ULN; aspartate transaminase (AST) ≤ 3×ULN; (leukemic infiltration is excluded).
Key exclusion criteria (10 listed)
- Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL
- T-cell acute lymphoblastic leukemia
- Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion
- Acute mixed phenotype acute leukemia (MPAL)
- Central nervous system (CNS) 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 |
|---|---|---|
| BlinatumomabInduction phase: 9 µg/day on days 8-14, 28 µg/day on days 15-21; If D22 BM not CR/CRi, continue Blinatumomab for next 2 weeks of 28 µg/day; Consolidation phase: 28 µg/day for 28 days. | Biological | Experimental Arm:Blinatumomab + Chemotherapy |
| Induction ChemotherapyReduced-dose induction regimen: Idarubicin 8 mg/m², intravenous, day 1; Vindesine 3 mg/m² (max 4 mg), intravenous, day 1; Dexamethasone 9 mg/m²/day, intravenous, days 1-7. Combined with blinatumomab | Drug | Experimental Arm:Blinatumomab + Chemotherapy |
| Hyper-CVADAlternating intensive consolidation chemotherapy: Hyper-CVAD-A: Cyclophosphamide ,Vincristine , Doxorubicin , Dexamethasone ; Hyper-CVAD-B: Methotrexate , Cytarabine . Alternated with CD19-CART and blinatumomab | Drug | Experimental Arm:Blinatumomab + Chemotherapy |
| Allogeneic hematopoietic stem cell transplantationAllogeneic hematopoietic stem cell transplantation, performed after consolidation therapy in patients with KMT2A rearrangement, TP53 mutation, persistent MRD positivity or MRD recurrence | Procedure or surgery | Experimental Arm:Blinatumomab + Chemotherapy |
| CAR-T cell therapyCD19-CART is administered sequentially in the consolidation phase: First infusion : Following the first course of blinatumomab (28 µg/day, IV, days 1-28) before subsequent Hyper-CVAD chemotherapy. Second infusion : After completion of alternating Hyper-CVAD and blinatumomab consolidation cycles. | Biological | Experimental Arm:Blinatumomab + Chemotherapy |
Primary outcome
2-year relapse-free survival (RFS)
Time frame: From enrollment through 2 years post-last patient enrolled
Defined as the time from enrollment to relapse, death from any cause, or last follow-up, whichever occurs first.
3 secondary outcomes
2-year overall survival (OS)
Time frame: From enrollment through 2 years post-last patient enrolled
Composite Complete Remission (CR/CRi) Rate after Induction Therapy
Time frame: From randomization to 2 cycles of induction before consolidation therapy(100 days)
Minimal Residual Disease (MRD) Negativity Rate
Time frame: From randomization to 2 cycles of induction before consolidation therapy(100 days)
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Suning Chen principal investigator
The First Affiliated Hospital of Soochow University
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 Blinatumomab, Induction Chemotherapy and Hyper-CVAD in people with B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, run by The First Affiliated Hospital of Soochow 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 10 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 4 May 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 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 Jing Lu Doctor (86+0512-67781137, gloriajlu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year relapse-free survival (RFS) (time frame: From enrollment through 2 years post-last patient enrolled). 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 4 May 2026.